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Jobs That Crossed My Desk Through Oct. 1, 2012 Complimentary Service of Audreysnetwork.com

Oct. 1, 2012

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. *************************************************************************** To apply for this position, please send your resume to apply-sn009@relypsa.com. Scientist - Analytical Chemistry at Relypsa Relypsa will soon be located in Redwood City and we are hiring! We are seeking a reliable, self-motivated professional for the position for a Scientist level in the Analytical Development Group supporting late stage drug development project. The position can be temporary or regular depending on applicable experience. ********************************************************************* Apply at company online Strategic Account Director (West) L&M Healthcare Communications - San Francisco Bay Area Job Description The Strategic Account Director creates, maintains, and expands relationships with West Coast clients. Assigned two to four clients, the Strategic Account Director is assigned strategic account objectives and will be responsible for providing strategic leadership on accounts, and for achieving new and organic business growth. **Must have LifeSciences experience** Ideal candidate will have excellent, proven, new business development skills. The Strategic Account Director represents the entire range of L&M services to assigned clients, while leading the client account planning cycle and ensuring assigned clients needs and expectations are met by L&M. The Strategic Account Director reports to the Chief Strategic Officer. Service

Establishes productive, professional relationships with key personnel in assigned accounts, keeping a finger on the “pulse” of the client

Enlists the involvement of L&M personnel, such as Project Management, Medical, and administrative resources, delivering on program/project objectives while meeting account performance goals and clients expectations

Strategy Acts as a trusted advisor on issues impacting the clients’ business Proactively assesses, clarifies, and validates client needs on an ongoing basis.

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Leads solution development efforts that best address client needs, while coordinating the involvement of all necessary L&M personnel

Sales Identifies new business opportunities through traditional and innovative approaches Initiates joint L&M-strategic account planning process that develops mutual performance

objectives, financial targets, and critical milestones for a one and three-year period Meets assigned targets for new/organic business growth and strategic objectives in assigned

accounts Desired Skills & Experience

Must be located in the SF Bay Area Four-year college degree from an accredited institution MBA-preferred but not required Minimum ten years of experience combined from agency/medical education account

management, bio/pharma product management, consulting, and new business development Must understand bio/pharma product marketing/ promotional medical education Oncology and CNS experience helpful This position requires extensive travel All prospective employees must pass a background check

Company Description L&M Healthcare Communications, is a KOL development, medical strategy & communications agency, located in Mountainside, NJ. L&M is composed of seasoned medical education agency executives, former bio-pharma manufacturer based marketers, and individuals with advanced degrees in medicine and the sciences. We are differentiated from other mid-sized agencies in that we have boutique divisions/services that address client needs through the product lifecycle.L&M Healthcare Communications L&M Healthcare Communications Additional Information Posted: September 11, 2012 Type: Full-time Experience: Director Functions: Strategy/Planning, Business Development, Management Industries: Marketing and Advertising, Biotechnology, Pharmaceuticals Job ID: 3727709 ************************************************************************ Posted by Jim Bishop - jdevice@bellsouth.net, President and CEO - Bishop Executive Services LLC Clinical Support Rep - Respiratory Specialist Los Angeles Now hiring: Clinical Support Rep - Respiratory Specialist Los Angeles http://www.ziprecruiter.com/job/Clinical-Support-Rep-Respiratory-Specialist-Los-Angeles/ff1a5e83/?source=social-linkedin-group-jobs ________________________________________________ Associate Medical Device Rep - Sacramento Now hiring: Associate Medical Device Rep - Sacramento (B2B background is great) http://www.ziprecruiter.com/job/Associate-Medical-Device-Rep-Sacramento/d958326d/?source=social-linkedin-group-jobs ********************************************************************** Posted by Eric Andrew Morse, Scientific Recruiter at R&D Recruiters Immediate hire for a Bioinformatician in Southern California! Now Hiring: Computational Biologist in Thousand Oaks, CA Job Description: Programming includes, but is not limited to, the data manipulation, analysis, and reporting of

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expression profiling data. Responsibilities: Specifically, creating analysis files, table/listing/graph generation, program validation and documentation and output verification. Experience Requirements: -Experience in classification methods and familiar with bioinformatics scientific literature. -Relevant work experience programming in computational biology or bioinformatics environment. -Will utilize R, Splus, or Matlab for data manipulation. Education Requirements: -Degree in computer science, statistics, mathematics, life sciences. *********************************************************** Posted by Giovanni Lauricella, Medical Device Search Consultant at The Mullings Group I would like to share more details with you and have a position description on the opportunity. Please contact me at Giovanni@MullingsGroup.com Neurovascular Clinical Program Manager in California – Growing division Looking for a strong clinical leader from the neurovascular space to join the rapidly growing team of my client in California. • Neurovascular clinical experience • Clinical ops and research heavily preferred • Currently in or willing to be in Southern California • Willing to travel 50% plus both domestic and international ****************************************************** Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com Alpha Consulting Corp. is seeking a CLINICAL SITE MONITOR for its client to work in LOS ANGELES COUNTY, CA REQUIREMENT #12-00539 RECRUITER: BRIDGET BURNS JOB LOCATION: LOS ANGELES COUNTY, CA LOCAL CANDIDATES ONLY!! This is a home-based position. Position located in Los Angeles County, CA with up to 40% coverage of Northern CA. Project Description: Perform/facilitate time-efficient pre-study initiation process. - Orient site personnel to study protocol/procedures - Monitor compliance to FDA Regulations and client’s SOP - Manage study site activities through frequent on-site visits and telephone contracts Required Skills: - Bachelor’s Degree - 5 years’ experience This 12+ position starts ASAP. ******************************************************* Posted by Alexander Cohen http://bull.hn/l/SQMS/

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Looking for a Sr. Product Development Associate for a Molecular Diagnostic Company in Irvine. Looking for a PRODUCT DEVELOPMENT ASSOCIATE / SR. PRODUCT DEVELOPMENT ASSOCIATE in Irvine, CA PRODUCT DEVELOPMENT ASSOCIATE / SR. PRODUCT DEVELOPMENT ASSOCIATE Simply Biotech specializes in recruiting exclusively for the biotech community. We are currently seeking multiple Product Development Associates / Senior Product Development Associates for a leading and growing Orange County firm. The Sr. / Product Development Associate is responsible for planning, conducting and analyzing experiments leading to validation of diagnostic tests in the field of methylation-related oncology. The selected candidate works in a team and needs to communicate relevant information to professional colleagues and to participate constructively in decision making that will impact the performances of the final product. The incumbent is responsible for compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO and state and federal requirements. The Product Development Associates / Senior Product Development Associates will: * Be responsible for the development and optimization of molecular assays in collaboration with others on assigned projects. Meets deadlines specified in overall project schedules. * Elaborate detailed protocols to validate research hypothesis and confirm product compliance with predefine expected performances. Plans and executes simple experiments independently. May plan complex experiments independently. * Perform lab work according to internal quality standards, document accurately the results and archive them accordingly in order to facilitate downstream work (intellectual property, regulatory affairs or research follow-ups). Maintains strict laboratory notebooks and research records. * Analyze results using statistical methods, control for consistency with previous work, summarize and communicate main outcomes to team members. * Participate in the evaluation and creation of new methods and procedures under the direction of the Director of Product Development. * Prepare technical reports, summaries, protocols and quantitative analyses that accurately and clearly communicate necessary information. * Participate in creation of all necessary documentation to support product manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols. * Apply professional concepts, in accordance with Company objectives to solve moderate to moderately complex problems in creative and effective ways. * Maintain high level of professional expertise through familiarity with scientific literature. May participate in scientific conferences and contributes to scientific journals. * Provide necessary training to Product Development team members and other personnel as required. * May be responsible for identifying patentable inventions. * Adapt to changes in processes, accepting approved changes and learning new tasks. * Participate in continuing education programs, (mandatory and non-mandatory). * Good knowledge and technical insight of molecular... ********************************************** Posted by Craig Charyak, Talent Manager R&D Partners is seeking a equipment engineer for a long term project in San Francisco, CA. Please send resume to: ccharyak@r-dpartners.com and/or call (415) 374-8872 Equipment Engineer in San Francisco, CA R&D Partners is seeking a equipment engineer for a long term project in San Francisco, CA. Please send resume to: ccharyak@r-dpartners.com and/or call (415) 374-8872 Scope of Work: o Assist with commissioning and qualification of the TFF Skid, three (3) Tanks, CIP Skid and

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distribution piping, one (1) Isolator and one (1) Spray Dryer. 1. TFF Skid: SAT & IOQ, protocol generation & execution on both 2. CIP Skid & distribution piping: IOQ execution 3. Isolator 1: SAT & IOQ, protocol edits only & IOQ execution 4. Spray Dryer 1: SAT & IOQ protocol generation & execution • Requirements: o BS in Chemical Engineering, preferred o Previous experience in the above mentioned equipment o 5-15 years of experience http://bull.hn/l/SQPR/1 ******************************************************** To view this position and other current positions please visit www.JGBBioPharma.com. Interested parties should contact/send resume to JBukar@JGBBioPharma.com. No Work Visa sponsorship is available for this job. Associate Director/ Director Clinical Operations - Full time Position (San Francisco Bay Area) PPBI DESCRIPTION: • Lead functional work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Clinical Monitoring] for global clinical trials. • Line management of CTA Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues. • Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project. • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs. • Develop and track FTE resourcing requirements and participate in headcount planning. • Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility. • Interact with Study Teams to ensure consistent functional performance and quality of work. • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables. • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed. • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials. • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations. • Ensure effective and efficient collaboration between internal customers and external providers (CROs). Liaise with internal (Study Management, Site Contracting, Central Services, etc.) and external (investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement. EXPERIENCE AND QUALIFICATIONS:

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• BA/BS or equivalent degree in life sciences or allied health field. • Minimum of 10 years experience in clinical operations roles, including at least 3 years of global clinical trial experience. Oncology or other complex clinical indication experience preferred. • Phase 2 or 3 experience preferred. • Line management experience required. • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must. • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate. • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment. • Demonstrated competency in leading cross-functional process improvement efforts. • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching. • Financial budgeting and resourcing planning skills. • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. Knowledge of medical terminology. ************************************************** Please apply on-line at www.questdiagnostics.com. Project Managers/Sr. Project Managers - Six Sigma - Location Flexible Quest Diagnostics - West Hills , CA (Greater Los Angeles Area) Job Description Quest Diagnostics (NYSE: DGX) is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Position yourself to be on the leading edge of change and become a subject matter expert in our company's new "Lab Operating Model". The "Lab Operating Model" proactively involves and engages all team members, on a consistent and regular basis, to drive continued improvements within our Operations. Seeking "Project Managers" – "Leaders” / "Change Agents” that have the skill and will to move our organization forward by providing strong leadership and oversight to accomplish the successful implementation of the "Lab Operating Model" within our Network. Coordinate the implementation of the "Lab Operating Model” within the business to meet targeted results. This will include facilitating the execution of detailed project plans, problem solving, directly supporting specific elements of implementation, communication, and facilitation. • Recognized "change agent", successfully enabled continuous improvement, demonstrated success in innovation or adoption of new ideas/processes • Drive and Commitment: Excited with the potential to move forward faster in their career, becoming a Subject Matter Expert in new Lab Operating Model and driving sustainable change to improve the company. • Problem Solving: Quantitative data analytics aptitude, ability to synthesize data to draw business conclusions. Solid analytical skills and conceptual thinking. Possess good business judgment and an understanding of Operations (Lab Operations experience helpful but not required. Experience in Continuous Improvement methodology, i.e. Six Sigma, Lean a plus. • Leadership: Possess strong leadership qualities and desires to take higher responsibility in the

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organization. Ability to influence and work hand in hand with all layers of the organization, to coach and develop capabilities of others; to drive projects and change. Able to work cross-functionally and at multiple levels in the organization • Communications: Show confidence and "presence in the room”, Demonstrate empathy along with effective oral and written communication skills. Ability to facilitate training modules and engage work groups. Excellent communication skills across multiple formats. Must demonstrate effective writing and verbal communications skills. • Responsible for the integration and effectiveness of the "Lab Operating Model” into our Laboratory Culture, driving employee engagement and continuous improvement within our Laboratory Operations. • Drive efficiencies and cost savings to meet project targets. • Help remove roadblocks and assist in higher level problem solving to enable continuous improvement. • Mentor Management Team Members to equip them to facilitate and understand the workings of the "Operating Model” within their team and the business. • Utilize Six Sigma methodologies in problem solving • Facilitate "Operating Model” training. • Coordinates the operational aspects of the "Lab Operating Model” implementation. Serves as liaison between the project team, Leadership, line management and team members. Assesses project issues and develop resolutions to meet productivity, quality, and client-satisfaction, goals and objectives. Intervene and problem solving with project managers, local Leadership and line managers • Championing "Lab Operating Model" through presentations, workshops and leadership forums. • On time and as expected achievement of strategic and operational goals. Location Flexible - Virtual office Qualifications: • BS or BA required • Project Management Certification or Black Belt certification preferred • MBA or MS preferred • A minimum of 5 years relevant work experience in the healthcare or pharmaceutical industry with ideally 2+ years experience in managing complex projects and teams; Six Sigma experience is highly desirable. • Recognized "change agent", successfully enabled continuous improvement, demonstrated success in innovation or adoption of new ideas/processes • Experience working in complex operations environments, ideally in multiple roles or functions. • Previous leadership experience. • Ability to influence in non-direct reporting relations and with all levels. • Strong team leadership skills • Drive and Commitment: Excited with the potential to move forward faster in their career, becoming a Subject Matter Expert in the new Lab Operating Model and driving sustainable change to improve the company. • Problem Solving: Quantitative data analytics aptitude, ability to synthesize data to draw business conclusions. Excellent analytical skills and conceptual thinking. Possess good business judgment and an understanding of Operations (Lab Operations experience helpful but not required. Experience in Continuous Improvement methodology, i.e. Six Sigma, Lean a plus. • Leadership: Exhibits excellent leadership qualities and desires to take higher responsibility in the organization. Ability to influence and work hand in hand with all layers of the organization, to coach and develop capabilities of others; to drive projects and change. Proven ability to work cross-functionally and at multiple levels in the organization • Communications: Show confidence and "presence in the room”, Demonstrate empathy along with effective oral and written communication skills. Ability to facilitate training modules and engage work groups. Excellent communication skills across multiple formats: e-mails, memos, conference calls, meetings and formal presentations. Must demonstrate effective writing and verbal communications

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skills. • Demonstrated ability to effectively facilitate teams. Proven ability to work collaboratively with teams as well as drive results. • Outstanding project management skills • Demonstrated ability to execute complex project plans, identifying resource needs, managing to milestones, effective problem resolution, managing inter-dependencies, driving for results. • Demonstrated ability to facilitate multiple projects, including coordination of multiple tasks and timelines, effective communication, coaching and support of teams to achieve results. • Ability to work independently with minimal supervision • Willingness to travel 80% domestically; ability to work varying shifts Equal Opportunity Employer Company Description Quest Diagnostics Incorporated (NYSE: DGX) is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers physicians the broadest test menu (3,000+ tests), is a pioneer in developing innovative new tests, is the leader in cancer diagnostics, provides anatomic pathology (AP) services, & interpretive consultation through its medical & scientific staff of about 900 M.D.s & Ph.D.s. The company has about 43,000 employees, serves approximately ½ of all physicians & hospitals in the U.S., & reported 2009 revenues of $7.5 billion. Quest Diagnostics offers the most extensive clinical testing network in the U.S., with laboratories in most major metropolitan areas, & in Mexico, the UK & India. The company also operates four esoteric laboratories, 40 outpatient AP laboratories, & 160 smaller, rapid-response laboratories. Patients may have specimens collected in any of the company’s approximately 2,000 patient service centers. On a typical workday, testing is performed for about 550,000 patients. With its MedPlus subsidiary, Quest Diagnostics empowers healthcare organizations & clinicians with state-of-the-art connectivity solutions. The company is the leading provider of pre-employment drugs-of-abuse screening for employers & risk assessment services for the life insurance industry. It is the world’s 2nd largest provider of clinical trials testing for new pharmaceuticals. Additional Information Posted: September 26, 2012 Type: Full-time Experience: Mid-Senior level Functions: Project Management Industries: Hospital & Health Care Job ID: 3831679 ************************************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-South-Region-Biotechnology-Jobs-Careers-30273 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Global Regulatory Affairs / RA Manager - Device Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description Partial Job Description 1) Develop a global product regulatory strategy for surgical devices 2) Obtain and maintain all US and EU approvals

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3) Develop and maintain EU Technical Files and ROW master files 4) Liaise with global regulatory counterparts to ensure regional requirements incorporated into product strategy development 5) Develop a product regulatory timeline aligned to company?s product development with key regulatory milestone and activities for agency filing 6) Coordinate with the team on the development of product labels 7) Ensure that labeling content and product documentation is developed in accordance with regulatory requirements 8) Participate as a member of the Product Development teams to build awareness of regulatory authority requirements and timing for submissions 9) Coordinate with RA global expansion team to ensure timely and accurate submissions to regulatory authorities 10) Act as a regulatory contact for assigned country regulatory authorities for surgical devices 11) Manage interactions with other company functions (e.g. Quality, Compliance) during regulatory authority inspections 12) Provide regulatory guidance/input to surgical device change control and internal product review boards TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: amehta@sterlinghoffman.net Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials.

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Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: September 27, 2012 Type: Full-time Experience: Mid-Senior level Functions: Science, Project Management, Quality Assurance Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 111270130273 Job ID: 3836456 ************************************************************************* To apply: Visit http://tinyurl.com/8t3rk86 Specialist,Clinical Manufacturing BioMarin - Novato, CA (San Francisco Bay Area) Job Description RESPONSIBILITIES This position is responsible for performing cell culture/fermentation and purification operations. They perform either cell culture/fermentation or purification operations with complete independence. They also help coordinate work with the junior staff. Other duties include troubleshooting minor equipment malfunctions, and training entry-level technicians. Essential Functions:

Compliance with safety guidelines Perform upstream and/or purification operations independently. Troubleshoot equipment and process failures Assist with equipment and process validation Provide leadership and training to more junior technicians Comply with cGMP Practices, Regulations, and Documentation Requirements Secondary Functions: Identify and purchase new spare parts for equipment as assigned Author maintenance work orders Implement departmental variance report corrective actions such as training and document

changes Perform support functions including inventory and stocking of supplies and raw materials,

chemical weigh and tracking, buffer and media preparation. Prepare, clean and sterilize process equipment including tanks, bioreactors, filtration systems

and lab ware. To apply: Visit http://tinyurl.com/8t3rk86 Desired Skills & Experience EDUCATION Bachelor of Science degree or equivalent work experience. EXPERIENCE Minimum of 2 years of directly related experience. Working knowledge of process and desktop computers. Highly developed organizational, leadership and communication skills. Experience with process development or process transfer preferred. To apply: Visit http://tinyurl.com/8t3rk86 Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for

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mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. EEO/M/F/D/V Additional Information Posted: September 28, 2012 Type: Full-time Experience: Mid-Senior level Functions: Manufacturing Industries: Biotechnology, Pharmaceuticals Job ID: 3849731 ************************************************************************* To apply: Visit http://tinyurl.com/9yv6mp7 BioMarin Manager, QC In-Process BioMarin - Novato (San Francisco Bay Area) Job Description SUMMARY The QC In-Process Manager is responsible for providing technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of biochemical and microbiological methods and routine In-Process testing. The position requires thorough knowledge and experience with HPLC, PCR, gel electrophoresis, enzyme kinetics, spectrophotometry, spectrofluorometry, other similar analytical tools and/or basic knowledge and experience with endotoxin, bioburden, rapid microbial testing as well as developed supervisory, organizational, and project management skills. It is expected that the incumbent will supervise senior supervisor, supervisor and four to five QC analysts and also work independently under minimal direction while accomplishing the timely completion of assignments. Good written and verbal communication skills are essential. Work activities will include, but are not limited to, participating in the preparation of sections of INDs, NDAs, BLAs, and in PAIs, reviewing routine testing results, preparing protocols and reports, performing UER, OOS and deviation investigation, providing cGMP and technical development for the staff, and interfacing with other internal and partner departments relative to quality issues. The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. RESPONSIBILITIES 1. Provide technical expertise, leadership, and perform analyses of Manufacturing and Clinical Manufacturing In-Process samples under cGMP to meet specified timelines. 2. Directly supervise QC Staff. 3. Perform primary review of QC raw data and trend results. 4. Prepare protocols, summaries, and reports. 5. Act as technical resource and train other analysts in areas of expertise. 6. Maintain the laboratory in an inspection-ready state.

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7. Conduct and document out-of-specification/out-of-trend result investigations. 8. Develop, optimize, validate and troubleshoot analytical test methods. 9. Draft written test procedures for new analytical methods. 10. Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary. 11. Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives. To apply: Visit http://tinyurl.com/9yv6mp7 Desired Skills & Experience EDUCATION For QC In-Process Manager: PhD with at least 3 years of experience in a relevant functional area, M.S. with at least 5 years of experience in a relevant functional area, or a B.S. with at least 8 years experience in a relevant functional area (at least 2 years in Quality Control). EXPERIENCE 1. At least two years in a cGMP laboratory, Quality Control experience preferred. 2. Demonstrate expertise with analytical methods used to assess pharmaceuticals and biologics, especially HPLC and other analytical tools. 3. Ability to work independently, managing projects and meeting established timelines. 4. Comfort with directing the activities of other staff members. 5. Computer literacy is required. 6. Experience with Microsoft Word and Excel are required. To apply: Visit http://tinyurl.com/9yv6mp7 Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. EEO/M/F/D/V To apply: Visit http://tinyurl.com/9yv6mp7 Additional Information Posted: September 28, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Biotechnology, Pharmaceuticals Job ID: 3849790 *************************************************************************

Posted by Isabelle Send resumes to ibrito@amrjobs.com

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We need specialty sales reps in San Diego, CA

We need specialty sales reps in San Diego, CA. Our client is a small, specialty pharma company that's rapidly expanding. They're looking for individuals with 3+ years pharma sales experience. Previous B2B experience is a plus, but not necessary.

*************************************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-California-North-Region-Biotechnology-Jobs-Careers-12568 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Clinical Laboratory Scientist Sterling Life Sciences - California- North Region (Greater Los Angeles Area)

Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Perform screening or confirmation tests in accordance with laboratory standard procedures 2) Perform confirmation tests on positive samples 3) Calibrate laboratory equipment as required 4) Provide assistance, training, and support for unlicensed testing personnel and new employees 5) Calibrate gamma counter and gas chromatographs daily 6) Prepare reagents 7) Read chromatograms 8) Interpret and Report RIA results, 9) Troubleshoot problems, 10) Review problem specimen 11) Perform equipment maintenance TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory

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Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility

Company Description

Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at:

http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm

We respect your privacy. Your resume will *never* be shared without your permission.

Please add our CEO on LinkedIn - your invitation will be accepted: amehta@sterlinghoffman.net

Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials.

Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume.

Additional Information Posted: September 21, 2012 Type: Full-time Experience: Mid-Senior level Functions: Project Management, Research, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 111264112568 Job ID: 3795565 *************************************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-Data-Statistics-California-South-Region-Biotechnology-Jobs-Careers-12433 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Project Manager - Data Management (Clinical) Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description

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Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Work collaboratively with clients, Clinical Research and Executive Management to ensure that data collected during clinical trials are processed according to corporate standards, client requirements and contract specifications and that the data meets FDA guidelines for data integrity 2) Act as primary liaison between Data Management and the client, other departments (especially Clinical Research) and external vendors for all matters related to the conduct of the Data Management component of a protocol 3) Manage and coordinate all aspects of the Data Management of a protocol in accordance with the contract, client requirements and corporate standards 4) Oversee and coordinate the day-to-day activities of the Data Managers, Data Processors and Programmers assigned to the protocol 5) Ensure that clinical data review policies, guidelines and procedures are followed during day-to-day processing of clinical data 6) Supervise the development and maintenance of protocol specific documentation as well as review and approve such documentation TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: amehta@sterlinghoffman.net Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume.

10/1/2012 16

Additional Information Posted: September 21, 2012 Type: Full-time Experience: Mid-Senior level Functions: Engineering, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 111264112433 Job ID: 3795585 ********************************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-South-Region-Biotechnology-Jobs-Careers-11880 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Regulatory Affairs/RA Associate Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Participate in the development of regulatory strategies and prepare regulatory submissions like US submissions that include IDEs, 510k and PMAs and EU submissions that include filing and amending technical files 2) Create, review and approve labeling 3) Approve labeling, including IFUs, packaging, etc. 4) Take responsibility for promotional labelling, including advertisements, promotional pieces and professional education materials 5) Maintain reports like Medical Device reports (MDRs) and EU vigilance reports 6) Represent Regulatory Affairs on various cross-functional teams like corrections and removals and functions as the recall coordinator 7) Review all news releases or other official company statements 8) Contribute to the development of the project plan and other deliverables 9) Represent Regulatory Affairs in the development of product plans, specifications, risk management and other required documents 10) Participate in design review when appropriate

10/1/2012 17

11) Create and revise procedures 12) Review and approve change orders and evaluate for submission requirements 13) Act as a standing member of the Corrective and Preventive Action Board (CAB) Complaint System, the Change Control Board and the Recall Team 14) Evaluate complaints for potential reporting obligation 15) Participate as an auditor, independently if appropriately trained 16) Take responsibility for Document Control, Design Control and Internal Audits 17) Determine if a correction or removal is necessary and if notification to any regulatory agency is required TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: amehta@sterlinghoffman.net Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: September 21, 2012 Type: Full-time Experience: Mid-Senior level Functions: Science, Project Management, Quality Assurance Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 111264111880 Job ID: 3795592

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******************************************************************* Jobs That Crossed My Desk Through Sept. 24, 2012

********************************************************************* My contact information is listed below. John Colantoni JWC Associates Phone: 732-792-2933 E-mail: jwchh500@aol.com Site Director for Pharma Co in Torrance, CA The particulars are; Salary range is $185 to $225, depending on experience Bonus is 25% 3 weeks vacation Relocation assistance. Position Description • This position will be responsible for management of all site opemtions including log istics functions, development and manufacturing operations along with QA, QC and regulatory support operations. Strategic planning. prepamtion and implementation of annual budgets, cost control, helping to ensure full compliance with GMP requirements and maintaining quality, service and on-time delivery for the US operation will be the critical areas of focus Management Responsi bility: • Oversee and coordinate a smooth integration of US operations • Lead and manage the development and ffillIlufacturing operations to ensure efficient production of products consistently meeting quality, quantity and time-line objectives. • Ensure thai the company maintains qualified well-trained staff, forefront technology and GMP compliant facil ities to maintain its leadership position in process d~lopmen t and cost-effective manufacturing of products • Take a leadership role in strategic planning and investments • Interact very closely with Global Sales & Markcting to ensure efficiency, nexibility and market responsiveness • Promote a smoolh and efficient cool>cration between Development and Production to ensure simple and cost effective start-up of production of ncw products • Oversee an integrated quality program to ensure continuous product and process improvement • Encourage communication and efficient cooperation across departments and other company sites. • Oversee logistics for project planning. cost control and supply of materials for production • OVCniee Quality Control and Quality Assurance to ensure timely GMP-compliant quality control ofraw materials Hnd fin ished API products, and full OMP compliance for all products manufactured in thc Torrance site • Oversee maintenance of buildings and equipment • Ensure efficient development of human resources through continuous perfonnance review and establishment of objectivcs for all personnel. • Preparation and realization of site expansion and other invesulIcnt projects • Actively implement policies and procedures established by the PPL Group. global functiomtl directors in terms of mnnufllcturing and development pmetiecs and human resources development. • Reporting of site pctfonnancc metrics. • Ensuring compliance with health, sarety and environment legislation.

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• Repon directly to the Global Director, Technical Operations Qualifications I Expericnce • Advanced degree in chemistry, biochemistry or chemical engineering; an MBA or similar is a plus • At least 10·15 years' expericnce in pharmaceutical or API GMP manufllcturing, with direct management cxperience in production operations. technical support and faci lity investments. • Experience in contract manufacturing, especially in peptide manufacturing, a plus. • Strong hands-on managerial and leadership ski!ls • A thorough undcr~tanding of QA, cGMP und pharmaceutical production • Well orgunized. highly motivated, action oriented team player with excellent interpersonal skills • Experience with the regulatory environment for the pharmaceutical business\ • The ability to lead and make decisions in un environment where projects require clarity of direction and the management of sometimes connicting requirements is important. *********************************************************************** Apply at company website Director of Marketing and Communications/Lead Generation – Medical Device Cutera - Brisbane (San Francisco Bay Area) (San Francisco Bay Area) Job Description The Director of Marketing will develop marketing programs and messaging that drive product awareness, interest, leads and adoption, by customer segment, for health care professionals and their patients. This individual will be responsible for assessing existing and potential markets, developing product strategies, forecasts, definition of promotional activities, and planning and implementing product launches. Activities include product advertising/promotion; sales tools and programs; planning, developing, and implementing multiple channel programs; and proving senior level input to the development of market requirements for specific product(s) or product line(s). This position will have strong customer relationships with and knowledge of the aesthetic dermatology and laser markets. Key responsibilities:

Collaborate with management to determine marketing strategies; align with company goals and objectives.

Responsible for the development and implementation of the overall downstream marketing strategy and plans, including product, application and channel strategy and plans to further company's revenue and profit objectives.

Develop marketing plans, forecasts and budgets. Partner with other leaders to accelerate the Company's market growth by achieving key

revenue objectives. Build and mentor marketing team through developing and attracting and marketing talent. Develop metrics that measure the value of marketing investments; ability to quickly analyze

data to determine ROI and change course accordingly. Select and direct internal marketing communication and product management teams and

outside vendors and agencies to insure that all marketing programs and materials are produced on time and within budget.

Direct strategy and implementation for professional meetings, tradeshows and user groups, include podium and adjunct event programs.

Work closely with Clinical Research to establish priorities to provide clinical evidence and claims for current products.

Utilize knowledge gained from experiences, market research and input from the medical community to develop co-marketing programs, sales programs and support materials to

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increase the sales of current products, as well as to provide input to Program Management for future products and/or enhancements.

Work closely with Program Management to establish priorities, identify new product opportunities and improvements & modifications to existing product lines. Collaborate to determine transition of products from upstream to downstream marketing. Oversee product launches.

Desired Skills & Experience BS/BA or equivalent with a minimum of 10+ years of related medical device marketing

management experience. MBA strongly preferred. Experience with dermatology and/or aesthetic products highly preferred; capital equipment a plus.

Strong managerial experience in a small to mid-sized company environment preferred; experience at large corporations and start-up experience a plus.

Track record of successfully growing teams and business in competitive markets. Experience marketing to both physicians/clinicians, and consumers. Strong strategic and execution skills. Strong leader who can inspire people to take action and accept accountability, incite in them a

sense of purpose and enthusiasm, and instill trust and credibility within and among teams. Able to convert product/customer feedback into valuable insights that can help drive the

development of new marketing programs or products. Strong communication and interpersonal skills; excellent analytical and organizational skills

necessary Excellent communication and presentation skills. Ability to travel 30% of time.

Company Description Cutera has been ranked on Forbes Magazine’s “200 Best Small Companies.” We design, develop, manufacture, and market medical instruments used in dermatology. Here's your opportunity to impact us. We seek exceptionally talented, capable, committed people to help shape and develop our company. We offer competitive benefits to all levels of employees. Cutera is an equal opportunity employer. Cutera was founded in 1998 with a goal of becoming the worldwide leading provider of laser and other light-based aesthetic systems to the aesthetic market. With our easy-to-use products, dermatologists, plastic surgeons, gynecologists, primary care physicians and other qualified practitioners can offer safe, effective and non-invasive aesthetic treatments to their patients. We commercially launched our first product, the CoolGlide® CV, in March of 2000 for hair removal, and every year since we have introduced at least one new product for our customers to treat additional aesthetic conditions. A key feature of our products is their upgradeable design; each time we introduced a new product, customers have been able to increase the capability of their earlier-generation systems by upgrading to the newest system for an incremental cost. This has provided our customers a cost-effective way to add new services to their patients. Our comprehensive product family is available on your choice of three platforms: Xeo – high performance, multi-application technology Solera – compact flash lamp or infrared technology CoolGlide – high performance laser-based technology Current applications of our product family include: permanent hair reduction on all skin types and tanned skin; treatment of vascular conditions, including leg and facial veins; a wide range of non-ablative skin rejuvenation applications; and the treatment of pigmented lesions. Additional Information Posted: September 14, 2012 Type: Full-time Experience: Director Functions: Marketing Industries: Medical Devices Job ID: 3747570 ***********************************************************************

10/1/2012 21

Apply at Legacy MedSearch at www. http://legacymedsearch.com/ Director of Marketing - Medical Device Vascular Robotics Legacy MedSearch - San Francisco (San Francisco Bay Area) Job Description Director of Marketing - Medical Device As Director of Marketing you will use your strong Business Development and Product Marketing experience, to lead the tactical and strategic management responsibilities for a complex medical/surgical product line. The ideal candidate will have demonstrated success in need identification and specification and will have led product introductions, developed and executed marketing plans, identified competitive threats, and cultivated key internal and external physician relationships. You should be adept in both presenting and message in a persuasive selling style and be a "team builder" as it relates to collaboration with an aggressive and high caliber direct Sales force. This marketing role requiring a calculated and analytical risk taker who has knowledge of heighten DOJ scrutiny relative to clinical and regulatory issues - but also someone who can create appropriate strategies to drive revenue growth and complying with relevant regulations. The position also requires a goal-driven, confident self-starter with the flexibility and capabilities to think strategically, execute on timelines to achieve key business goals and influence a wide array of key partners. Position Responsibilities

Approximately 30% of your time will be directed at working with Surgeon / Physician / Clinicians where you will manage need identification in your upstream marketing capacity. Working with your colleagues in R&D, Product Development, Sales, and KOLs, you will develop marketing plans and activities for the product line to establish, enhance or distinguish product placement within the competitive arena.

Approximately 30% of your time will involve capitalizing on your prior engineering, clinical, or scientific experience as you collaborate in sourcing, negotiating, and executing key strategic business development deals to drive both organic and inorganic growth through acquisition or strategic development.

Approximately 30% of your time will be spent in program management on current and new products and enhancements, including product roadmaps, PLC management and then effectively communicating product strategy to the organization with a strong emphasis on sales and external constituents.

Represent the company at tradeshows, academic, and specialty meetings where you will become an expert on both the technical and clinical aspects of the product as you lead advisory panels and user groups.

Develop responsible promotion strategies to capture increased market share and to grow momentum and continued high morale of the sales force, as well as develop and lead sales training activities.

You will lead the development of luminary publications, clinical white papers, sponsored studies and work with leading researchers and universities and develop post marketing protocols to support clinical and marketing efforts.

Desired Skills & Experience Director of Marketing - Medical Device Education Requirements:

Bachelor’s degree ++ in science or engineering or related discipline and 7-12+ years of progressively increasing experience successfully managing various facets of marketing and business development programs.

MBA and/or Clinical experience is also highly desired. Position Requirements:

7-12+ years marketing experience in medical device industry with strong preference for cardiovascular device experience.

Experience in leading new product development efforts form both a technical / specification standpoint and a branding / messaging standpoint.

10/1/2012 22

Ability - and desire - to work in an extremely entrepreneurial environment with moderate supervision.

Demonstrated process development and implementation skills tempered with the flexibility to be results oriented in a fast-paced environment.

Experience with the marketing of complex, medical capital equipment is desirable. Specific clinical, vascular, or interventional cardiology marketing experience is a strong plus. Strong written and verbal skills - you should be a persuasive, engaging, and clinical credible

presenter in working with both physicians and customer-facing colleagues. Additional Information Posted: September 10, 2012 Type: Full-time Experience: Mid-Senior level Functions: Marketing Industries: Medical Devices Compensation: 140,000-163,000 Employer Job ID: 921 Job ID: 3716036 ********************************************************************* Apply at: Submit qualified resumes to: careers@freeslate.com Product Marketing Director, Chemical & Energy Freeslate Inc. - Sunnyvale, CA (San Francisco Bay Area) Job Description JOB SUMMARY: The Product Marketing Director will be responsible for developing and implementing a global marketing strategy for sales into Chemical and Energy market segments, identifying new product opportunities and current product improvements, creating effective marketing campaigns and promotional materials, and providing sales and internal product support. The position will report to the Vice President of Marketing and Strategic Planning. Up to 40% travel required. JOB RESPONSIBILITIES:

Ensure the voice of customer is represented in product development and product strategy at Freeslate for the Chermical and Energy market segments

Develop strategic and tactical plans to assure success in the Chemical and Energy market segments including identifying strategic opportunities and threats to Freeslate.

Define requirements and provide market input into a cross-functional process to conceptualize and execute new products

Manage all marketing aspects of product development projects, as part of a cross functional team, including market requirements, pricing strategies, financial analysis and sales forecasts, product literature and user information.

Define and execute product launch plans to include promotional plans, manufacturing forecasts, sales training plans, and support plans.

Formulate and continuously update value propositions for each market segment, with resultant positioning statements and major messages

Work with the sales organization to create and attain performance goals for the Chemical and Energy market segments

Provide product training and marketing support to field sales, applications and technical support personnel

Drive processes for identifying and rectifying product problems Create, approve and manage promotional plans, including product literature, trade shows,

space advertising, direct mail, web pages, newsletters, etc. REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

Bachelor's degree in chemistry, chemical engineering, or combination of equivalent education and work experience. Ph. D. preferred.

10/1/2012 23

3-5 years marketing and/or product management experience ideally in the Chemical or Energy markets.

5-7 years overall work experience in a technically related field. Experience with automation is preferred. Demonstrated understanding of the chemical development process including a working knowledge of current pain points in discovering and developing new catalysts.

Experience in working with large chemical and petrochemical companies Understanding of the development of polyolefins and/or bio-based chemicals Experience in applying automation to scientific applications. Understanding of what is critical

for the success of an automated solution for chemical applications. PREFERENTIAL QUALIFICATIONS:

Successful track record defining customer requirements, reaching the customer (e.g. surveys, promotions, tactical marketing communications), working on product development teams, launching products and managing product life cycles.

Ability to analyze and dissect competitive information, market research, and customer data and use it to make sound recommendations.

A creative thinker with excellent written and verbal communication skills. Good organizational skills with the ability to prioritize and manage multiple projects

simultaneously. Ability to work effectively with cross-functional teams to achieve product launches

Freeslate is an Equal Opportunity Employer that is committed to diversity and inclusion. Our hiring decisions are made without regard to race, color, religion, creed, disability, genetic information, national origin, gender, gender identity and expression, age, sexual orientation, marital status, or veteran status. Company Description Freeslate is a privately held company of ~100 employees that provides products and related services for high throughput research. Based on its proprietary laboratory automation platforms, high throughput pressure reactors, and integrated Lab Execution and Analysis (LEA) software suite, the company enables dramatic gains in its customers’ productivity and innovation by delivering seamlessly integrated automation solutions. Freeslate leverages its scientific expertise through its team of Ph.D. scientists, engineers, and software developers with directly relevant experience in the industries it serves. Collaborating with customers for more than a decade, the business has provided high throughput research solutions for the pharmaceutical, chemical, energy, and consumer products industries. The company is headquartered in the heart of Silicon Valley in Sunnyvale, California, with direct sales and service in North America, Europe and Asia. We have comprehensive and competitive compensation and benefits offerings with a comfortable and collegial work environment. If you are interested in working with leading edge technologies with the brightest minds in high throughput research, Freeslate is the place for you. Additional Information Posted: September 12, 2012 Type: Full-time Experience: Mid-Senior level Functions: Marketing Industries: Biotechnology Employer Job ID: L74 Job ID: 3640022 **********************************************************************

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Professionals in the Pharmaceutical and Biotech Industry

If you are qualified and interested please contact me privately: dave@alpinesearch.net Dave Murphy The Alpine Group

Biotech Associate Director of Marketing - SF Bay area Small company. Big Plans.

A start-up client of mine has asked me to help them fill a newly create Associate Director role in their marketing group. Publicly traded with a market cap of nearly 200M, they will be launching their first product next year, a specialty drug in the metabolic market. Their second drug is moving into Phase III early next year. The role is a broad mix of strategic and tactical work, and will include marketing programs for Health Care Professionals as well as Patients. Qualfications: - 7+ years of pharmaceutical or biotech marketing experience, including strategic and tactical work • Small brand marketing experience working with a specialty product (not strictly primary care experience) • Product launch experience in a specialty drug market • A mix of health care professional and patient marketing experience (DTC / DTP) • Experience coordinating ad agency activities • Bachelor’s degree or better is required; MBA is preferred

*****************************************************************

Contact Eric Andrew http://bull.hn/l/S3MK/4

Open Research Associate position at a SoCal biopharma giant!

Now Hiring: Research Associate, Molecular Characterization in Thousand Oaks, CA Job Description: Discovery Analytics department is looking for a research associate to provide state of the art biophysical method support to Amgen’s therapeutic discovery efforts. Responsibilities: The work encompasses kinetic, thermodynamic and structural characterization of small molecule – protein and protein – protein interactions using a wide range of biophysical techniques such as SPR spectroscopy,

10/1/2012 26

ITC, and NMR. Requirements: -The candidate should have a degree in chemistry, biochemistry, molecular biology or equivalent and possess experience with standard protein biochemistry techniques. -Previous experience with label-free SPR spectroscopy and/or NMR spectroscopy is a plus.

*********************************************************** Apply for Alpine Group listings at website at http://www.alpinesearch.net/ See pay details etc. in online listing BioPharma Market Research Group Manager The Alpine Group - San Francisco Bay Area Job Description Our client is a start-up biopharmaceutical organization with four products in clinical development for metabolic and neurological disorders, and they need someone to lead a small team working in strategy and analytics. Now publicly traded and with over 300M in the bank, they are expanding their commercial team and need a world-class market research professional to help take them to the next level. The stock price has tripled this year and they are doubling the size of the organization over the next year. They provide an exciting work environment where their teams have unusually strong personal chemistry. If you are looking to be a pacesetter and company architect in a high-potential start-up then this could be the opportunity for you. The Opportunity: The Group Manager of Strategy and Analytics will help build a market research, forecasting and competitive intelligence program to support the launch of several high potential new compounds. Working in a small commercial environment, this will be a broadly defined leadership assignment where you will “wear many hats” and duties will vary significantly from week to week. The first challenge will be to prepare for the launch of a first-in-class drug by year’s end, including finalizing the messaging, branding, pricing and go-to-market strategies. You will also establish operating procedures for primary and secondary market research (both qualitative and quantitative), forecasting, war games, and patient longitudinal studies. One to two Analysts will be assigned to this position within one year, depending on the success of the first product launch, so the role will require leadership and developmental skills. The team will be expected to build a Center of Excellence for large scale quantitative research, including conjoint analysis and discreet choice modeling, and you will present and defend recommendations to support the long-term strategic planning process. This is a broadly defined assignment so you will interact with senior management on a routine basis. Their rapidly expanding organization means there are significant opportunities for career development and advancement. Desired Skills & Experience The successful candidate will have the following qualities:

5+ years of market research and analytics experience in the pharmaceutical or biotech industry (medical device experience will also be considered)

Primary and secondary market research experience, as well as extensive forecasting and modeling. Experience working directly for a manufacturer is required, rather than exclusively in consulting or as a supplier / vendor.

Strong quantitative research skills, including conjoint analysis or discreet choice Bachelor’s degree or better; MBA strongly preferred Strong leadership and interpersonal communication skills, and the ability to help set a vision

for the future of the marketing organization Company Description The Alpine Group serves only the Medical Technology industry, including the Pharmaceutical, Biotech, Medical Device and Diagnostic markets. Our clients choose us because we are specialists rather than

10/1/2012 27

generalists. As niche recruiters, we bring our clients market mastery, trusted counsel and - most of all - expedited results. Since 1999, we've helped over 125 different medical technology organizations hire Impact Players in positions ranging from individual contributor to Chief Level leadership. Our current client list includes large, multinational organizations like Novartis and Medtronic down to small, emerging organizations - including start-ups. The Alpine Group has achieved the MRI Network "President's Club" award for top 20% performing offices each of the past eight years, winning the Regional Office of the Year Award six times since 1999. Our recruiting approach differs from the majority of other recruiting firms. We invest time in getting to know about each candidate's career interests and qualifications and only then do we present an opportunity that might be a fit, rather than emailing a job description and asking who they may know that would be interested. With this approach we can not only match great people with great opportunities, but we also know when to contact them again when new opportunities arise that might be of interest. Our approach takes more time up front, but pays big dividends later for clients who need to hire quickly and candidates who appreciate the efficiency and candor. We think you'll find that the recruiting experience you'll have with us is different from what you may have experienced with other Search Consultants in the past. Give us a call and see what The Alpine Group can do for you! Additional Information Posted: September 5, 2012 Type: Full-time Experience: Mid-Senior level Functions: Marketing Industries: Pharmaceuticals Compensation: 120-145K + bonus + stock Job ID: 3693636 __________________________________________________ Field Based Reimbursement Policy Position The Alpine Group - San Francisco Bay Area Job Description The Company My client is a biotech leader with numerous products on the market, some of which are orphan products. They're planning tremendous growth with our newest injectable product and we are expanding our organization. They are adding a newly created position that will impact the lives of our patients, your career and the future growth of the company. You would be the lead on the proverbial front line and your input is crucial to our future business strategies. Because the disease our product treats is rare and is focused on a condition which more or less had to go untreated, someone with a passion for seeing positive end results is a plus. This is not a cough and cold company focused on volume, but rather on quality. The Job This is a critically important position. You’d be responsible for working with Medicare carriers to ensure a favorable reimbursement policy. In addition, you’ll create and manage key relationships with advocacy groups, KOL’s and legislators as well as provide reimbursement expertise to physicians and resource support for the sales team. This position is based in Northern California, Oregon or Washington. Desired Skills & Experience There are a few “Must Haves” for this position. · A demonstrated track record of success · Experience gaining reimbursement policies with Medicare Carriers and building relationships with them

10/1/2012 28

· Experience with buy and bill and J codes · Experience working with a sales force and providers as the reimbursement expert on coding questions and issues An attractive compensation package for this position includes a competitive base salary, an above average annual bonus based on company and individual performance. This is an opportunity to leverage your technical experience and relationships for something more than a simple paycheck. If this sounds like the type of environment you are seeking at this point in your career, and if your background meets these qualifications, please apply. We want to give you the opportunity to succeed. Company Description The Alpine Group serves only the Medical Technology industry, including the Pharmaceutical, Biotech, Medical Device and Diagnostic markets. Our clients choose us because we are specialists rather than generalists. As niche recruiters, we bring our clients market mastery, trusted counsel and - most of all - expedited results. Since 1999, we've helped over 125 different medical technology organizations hire Impact Players in positions ranging from individual contributor to Chief Level leadership. Our current client list includes large, multinational organizations like Novartis and Medtronic down to small, emerging organizations - including start-ups. The Alpine Group has achieved the MRI Network "President's Club" award for top 20% performing offices each of the past eight years, winning the Regional Office of the Year Award six times since 1999. Our recruiting approach differs from the majority of other recruiting firms. We invest time in getting to know about each candidate's career interests and qualifications and only then do we present an opportunity that might be a fit, rather than emailing a job description and asking who they may know that would be interested. With this approach we can not only match great people with great opportunities, but we also know when to contact them again when new opportunities arise that might be of interest. Our approach takes more time up front, but pays big dividends later for clients who need to hire quickly and candidates who appreciate the efficiency and candor. We think you'll find that the recruiting experience you'll have with us is different from what you may have experienced with other Search Consultants in the past. Give us a call and see what The Alpine Group can do for you! Additional Information Posted: September 13, 2012 Type: Full-time Experience: Mid-Senior level Functions: Other Industries: Biotechnology, Pharmaceuticals, Medical Devices Job ID: 3743521 _____________________________________________________ Job Title Clinical Trial Manager Location San Francisco, CA Min Salary $120,000.00 Max Salary $150,000.00 Incentive Compensation 15% Bonus Job Type Full-Time Regular

Job Description

One of the world’s largest and most respected medical device companies is expanding and looking to add a management level person within their Clinical Research Team. The title is Clinical Project Manager, and this person will be leading 8 Clinical Scientists on a dotted-line basis. This organization has been around for over 60 years, and they boast one of the lowest attrition rates in any industry, leading them to be a perennial company found on the Fortune’s Top 100 employers. They have a first-in-class device they are developing, and you can be leading the trial for it! Responsibilities:

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The Clinical Project Manager will represent the Clinical Research Team driving strategy and development. You will be presenting to executive management your strategy for the trial of this new product, which is unlike anything in the market. So, you will be the expert driving the execution and oversight of the study—coordinating activities, maintaining compliance, reporting adverse events, and reviewing audit reports, while managing the output of 8 Clinical Scientist on a dotted line basis. This position reports directly to the Director of Clinical Research, so this is a high visibility role. This position is based in the Bay Area, CA. Qualifications: • MD degree, OR Doctorate degree in Life Science/Engineering/Public Health • 5+ years of clinical research experience in medical/scientific area • 3+ years of running clinical trials • 3+ years of management experience An attractive compensation package for this position includes an extremely competitive base salary and an annual bonus based on company and individual performance. A comprehensive benefits package is also provided. They are looking for ambitious people who can see themselves being quickly promoted two levels above this one. If you are a motivated, self-starter who would like to help this organization grow, and if your background and qualifications meet these specifications, please respond by e-mail or fax. Please apply online or E-mail your confidential resume (in Microsoft Word, Rich Text Format, or text format) to resume@alpinesearch.net. If unable to E-mail, please send via fax to (970) 241-4395. Please reference 3057 in the subject line of your email or in your fax cover letter. YOUR PERSONAL PRIVACY AND CONFIDENTIALITY ARE GUARANTEED. NO TELEPHONE CALLS PLEASE. Due to the high volume of resumes received, only applicants with specific experience requested by our clients will be contacted. Additional opportunities are available throughout the country. Click here to see our list of available positions. SALARY: $120,000 - $150,000 BONUS: 15%

********************************************************** Apply at www.onyx.com Director Product Strategy, US Marketing, Prl Franchise Onyx Pharmaceuticals - Corporate Office (San Francisco Bay Area) Job Description Summary The Director of Strategy for the US PrI Franchise Marketing Team will lead the development of strategic initiatives for the Franchise, including serving as the US strategic planning lead for KyprolisTM (carfilzomib) for Injection. Essential/Primary Duties, Functions and Responsibilities

Leads strategic planning for US PrI Franchise Marketing Team. Leads brand input into cross-functional strategic activities.

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Key areas of responsibility include developing the franchise brand plan, serving as point for quarterly business reviews, partnering with global analytics on market research projects, and leading the launch planning for potential new indications for Kyprolis and competitors.

Interprets and translates chart audits, ATUs, and sales trends into commercial strategies. Strong ability to collaborate with cross-functional teams. Must work cooperatively with global

marketing, global business analytics, market access, commercial management, clinical development, medical affairs, regulatory, compliance and others.

Closely manages & tracks US Marketing team’s budget. Ensure compliance with all relevant laws, regulations and policies. Develop and deliver presentations as needed to commercial management and other internal

groups Desired Skills & Experience Requirements Work Experience:

10+ years related work experience in product marketing, market analytics, field sales, market research or management consulting in the pharmaceutical/biotech industry

Hematology experience preferred, oncology experience a plus Experience in multiple myeloma a plus Launch experience preferred

Management of Staff: No Direct reports upon hire

Functional/Technical Knowledge & Skills:

Strategic thinker with the ability to formulate, develop and execute comprehensive plans Strong ability to analyze market research and translate insights into actionable strategies Strong influence & presentation skills Excellent organizational, analytical and problem solving skills

Customer & Industry Knowledge: Demonstrates knowledge of the oncology /hematology marketplace including an understanding

of the business drivers behind community practices and emerging oncology market trends Knowledge of pharmaceutical industry, relevant regulations and laws

Education/Training: Bachelors Degree required MBA or other Master’s degree a plus Scientific background preferred

Other Requirements: Highly motivated, ability to be effective in a rapidly changing, small company environment Ability to thrive in ambiguity Strong project management skills

Competencies Functional competencies in executing strategic plans, developing promotional strategies,

interpreting market research, understanding sales trends Behavioral competencies in working with teams, collaboration in an unstructured, rapidly

growing environment Demonstrated understanding of the required elements for successful partnership with field

sales Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information

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Posted: September 10, 2012 Type: Full-time Experience: Mid-Senior level Functions: Marketing Industries: Pharmaceuticals Job ID: 3717033 ******************************************************************* Apply at Real Staffing San Francisco Bay Area office Associate Director, Clinical QA Real Staffing Group - San Francisco Bay Area Job Description Exciting biopharmaceutical oncology company in the SF Bay Area is looking for Sr. Manager, GCP to help manage and build up the Clinical QA department. This position reports into the Director, Clinical QA and will help assist with all aspects for Clinical QA (build a clinical Quality System, attend and lead clinical site audits, help to manage the Clinical QA team. Desired Skills & Experience Job Requirements:

Ensuring compliance of clinical development activities and initiatives to applicable quality and regulatory requirements

Developing, revising or assisting with quality system SOPs for GCP QA and Clinical Operations in compliance with applicable regulatory requirements

Support GCP QA audit activities for assigned studies/projects Participating in budget forecasting, planning and tracking for GCP QA Providing expert GCP QA advice to Clinical Operations based on analysis and interpretation of

updates to GCP regulations to assure best Clinical/QA practices Develops, coordinates, conducts or supervises targeted training to Clinical Operations (e.g.: on

SOPs), investigators/site staff (e.g.: GCP presentations for investigator meetings) and others (e.g.: Regulatory Affairs)

Assists with oversight and management of consultants on as needed basis Assists with the organization, preparation, coordination, and documentation of regulatory

inspections of investigator sites or Clinical Operations sponsor inspections Qualifications:

BS in a scientific related field 10 years experience in the Pharmaceutical/Biotechnology Industry Minimum of 5 years in GCP QA Experience with hyper tension, breast cancer, or prostate cancer is a plus Experience auditing IVRS and EDC and computer systems is a plus Project manager experience is required Experience building a clinical Quality System from the ground up

Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Accountancy - Banking and Finance - Engineering - Healthcare - IT - Pharmaceuticals and biotech - Public Sector and Government Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product

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cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted: September 24, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Pharmaceuticals, Biotechnology Job ID: 3807865 ************************************************************************* If you are interested in this opportunity please forward your CV or for further information, you can contact me on the details below. Monica Ball Real Staffing - Pharma Division Tel: +1 617 737 8101 Email: m.ball@realstaffing.com

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Director, Project & Portfolio Management Cambridge, MA My client, a Global Biopharmaceutical firm based in Cambridge, MA is seeking a Director of Project and Portfolio Management. Specializing in ultra-rare disorders, this biopharmaceutical firm is growing, offers a fun work environment, and career growth. This position will allow you to facilitate the transition of new compounds from research to development. You will be reporting to the VP and Head of Translational Medicine, you will be supporting the efforts in facilitating the transition of new compounds from research to clinical development. You will also be developing cross functional project teams and applying project management. Daily Responsibilities Include: Driving the development and managing the execution of high quality and integrated cross-functional plans Performing tasks such as administrative tasks including creating and maintaining project plan documents, meeting scheduling and facilitation, and agenda creation Directly planning schedules and monitoring the budget and spending Communicating and managing relationships with cross-functional team members Keep stakeholders informed with all key project details Involved in focusing on strategic problems across functional areas of the business Travel (10-20%) Qualifications Include: Ideal – PhD (relevant to biological sciences) 8 to 10 years experience in drug discovery and development within biotech/pharmaceutical industry Extensive experience with IND application filings (ideally for protein therapeutics) Extremely knowledgeable of preclinical and nonclinical development, regulatory requirements for IND filing of protein therapeutics, clinical development/trial process Driving cross-functional working teams for preclinical, IND and early clinical activities PMP certification is a plus and experience in

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ophthalmology drug development is desired ************************************************************************** Posted by Cheryl Ward, CIR, Executive Recruiter at SciStaff Services, LLC Local Candidates only please! If you meet the above requirements, please forward a copy of your resume (word format) to oy2ii7@j.postjobfree.com for confidential review. NOTE: Due to the volume of resumes we receive, we are only able to respond to those that meet the requirements for this position. United States

State: California City: Santa Clara ZIP: 95054

Job type: Full-time Company Name: SciStaff Services

Posted date: 9/20/2012 Joined: 3/8/2011 all jobs all comments

Job Description: My client, a Top 10 pharmaceutical company is seeking a Clinical Paralegal to work with them in Santa Clara, CA for approximately 6 months. He/she will review and negotiate legal language for clinical trial agreements, statement of work and amendments, and will respond to proposed modifications and negotiate with sites as needed. Requirements: Bachelor’s degree (preferred). Paralegal certification (preferred). 2-5 years of applicable experience specifically working with legal language in clinical trial agreements Working knowledge of general legal concepts, terminology and principles related to contracts. Ability to operate independently with limited attorney supervision, while adhering to department policies, procedures and negotiation parameters. ********************************************************************* To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact JBukar@JGBBioPharma.com. No Work Visa sponsorship is available for this job. Manager, Clinical Trial Materials Management – Full Time Position (SanFrancisco Bay Area) PPBI DESCRIPTION: • Reports to Associate Director, Manufacturing and CMC Development, Drug Product. • Lead CTM planning and logistics activities, including coordination of manufacturing activities with Manufacturing, Contract Manufacturing Organizations, and distribution vendors. • Develop study specific packaging, labeling and distribution strategies with Clinical Operations, CROs and other approved vendors.

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• Prepare and maintain a current worldwide clinical trial materials forecast and routinely update Clinical Operations and Technical Operations (Supply) on requirements. • Oversee all initial and re-supply of CTM to clinical sites. Initiate packaging and labeling operations to ensure a continuous supply of CTM is available for ongoing studies. • Interact with corporate partners and cross-functionally with Regulatory Affairs, Technical Operations, Clinical Operations and Project Management to ensure a continuous supply of CTM that is compliant with all Regulatory requirements and applicable quality standards. • Oversee vendor selection for CTM packaging, labeling, release testing, storage, import/export, and distribution functions. • Collaborate with Clinical Operations in the development of pharmacy manuals and other training materials for site and pharmacy staff. • Collaborate with Clinical Operations and Clinical Data Management in the selection, development and implementation of Interactive Voice/Web Response System (IXRS) to support clinical programs. • Monitor IXRS functions for treatment assignment and inventory management. • Manage CTM-related product complaints to ensure adequate investigation and documentation of reports of concern from staff, clinical sites and health care providers regarding investigational products. • Monitor and track retest and expiry dates for materials in use in on-going clinical trials to ensure current material availability. • In conjunction with QA and Clinical QA, identify, author, and assure compliance with all GMP- and GCP-mandated Standard Operating Procedures, Work Instructions, and Guidelines applicable to the supply of CTMs. EXPERIENCE AND QUALIFICATIONS: • BS or equivalent in Pharmacy, Chemistry, or closely-related field and at least 8 years of experience in pharmaceutical development, manufacturing or logistics, including at least 5 years of global CTM management experience. • Working familiarity with current GMPs and GCPs as related to supply of CTMs. • Experience with CTMM, vendor management, forecasting and logistics strongly preferred. • Experience with large placebo-controlled global clinical trials is strongly preferred. • Experience with injectable parenteral formulations and sterile product manufacture is desirable. • Excellent organizational/coordination skills with attention to detail. • Strong verbal and written communication skills with the desire and ability to influence others. • Demonstrated proactive approach; willing and able to take initiative/follow-up to assure CTM availability. • Flexible and able to adapt to the needs of a project team with cross-functional membership. • Proven ability to manage multiple tasks within a multidisciplinary team environment. • Proficient in use of office-based software systems (e.g., Word, Excel, PowerPoint). • Proficient in use of databases for the tracking of supply, distribution, reconciliation and forecasting of CTM. • Able to travel approximately 10% of time. Margaret Imperiale, Administrative Services www.JGBBioPharma.com Supply Chain Operations Jobs jgbbiopharma.com Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good... ____________________________________________

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To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should send resume to LSantiago@JGBBioPharma.com. No relocation and Work Visa sponsorship is available for this job.

Senior Data Manager – Full Time Position (San Francisco Bay Area) PPBI DESCRIPTION: The Senior Manager, Associate Director is responsible for overseeing all Data Management (DM) operational activities ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide study data. This includes but is not limited to vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting. This position reports to Head of Biometrics. Specific Duties • Participate in vendor and technology (e.g., EDC) evaluation, qualification and selection. Involved in RFP development and contract negotiation, as needed. • Oversee and manage all DM related activities outsourced to DM SP as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget. • Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities using established FGN templates/processes as applicable (e.g. FGN DM standards include CRFs, Completion Guidelines, edit check specifications, metric/status reports, transfer agreements, DMP template, medical coding conventions, etc.). • Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring established standards. • Review study data for completeness and general clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations. • Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed. • Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM vendors via regular process auditing. • Participate in the development of SOPs, working practices, DM standards, policies and Clinical Development process improvement supporting clinical data management activities. • Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times. EXPERIENCE AND QUALIFICATIONS: • Bachelor’s degree in a relevant scientific discipline or equivalent • Minimum of ten years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, or equivalent • Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus • Knowledge and experience with various clinical databases (e.g., Clintrials, Oracle Clinical,

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SAS) and key technologies (e.g., EDC, Scanning/Imaging, IVRS/IWRS) • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required ************************************************************************ Apply on company website Director / Sr. Director, CMC Regulatory Affairs Pharmacyclics - San Francisco Bay Area Job Description The Director/Sr. Director of CMC Regulatory Affairs acts as the CMC regulatory lead by providing regulatory strategy and support to global development teams and facilitating all regulatory filings relating to CMC. Key Accountabilities/Core Job Responsibilities:

Develops CMC regulatory strategy for PCI-32765 Represents RA CMC at project team meetings and coordinates regulatory workflow

between departments as well as CROs Coordinates, writes, compiles CMC document packages and investigational drug

shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs

Regulatory lead for module 3 of upcoming eCTD filings Acquires and maintains current knowledge of applicable regulatory requirements and

scientific/technical issues in the area of small molecule pharmaceuticals. Regulatory Lead for interactions with regulatory authorities on CMC issues. Participates in Regulatory Affairs initiatives to improve PCYC standards and systems.

Desired Skills & Experience Ability to manage multiple and varied tasks in a fast-moving environment, good record-

keeping skills Proficient with computer (MS Office) and internet skills. Strong interpersonal skills and a proven ability to contribute to a team environment

involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.

Proven ability to communicate with executive management, cross-functional team members and operational staff.

Flexible attitude with respect to work assignments, and new learning. 8+ years relevant regulatory CMC experience BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent)

Company Description Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Additional Information Posted: September 6, 2012 Type: Full-time Experience: Mid-Senior level

10/1/2012 38

Functions: Science Industries: Biotechnology Job ID: 3700153 ***************************************** Posted by Posted by Susan Halstead, TriVascular Careers trivascular.com TriVascular in Santa Rosa, CA is looking for a Customer Service Specialist to join growing team! Check out our website to learn more about this position. Dedicated to serving patients with aortic disease, TriVascular is committed to providing optimal solutions for endovascular aortic repair... ************************************************************************* Cindy Johnson CEO, President Chozen Inc. cell: 925-577-8135 cjohnson@chozeninc.com www.chozeninc.com We have a client with an urgent need for a Principal & Sr. Design Quality Engineer with a strong background working with catheter technology and electromechanical systems. Principal Design Quality Engineer

BS in Engineering is required, MS or PhD would be a plus 8+ years of quality engineering and/or R&D experience within medical device Experience applying ISO 14971, IEC 60601-1 and related standards to product design &

development Catheter and RF electromechanical systems experience preferred Skilled in the application of statistical methods DFSS or DMAIC Black Belt Certified CQA, CQE certification preferred

Sr. Design Quality Engineer

BSEE or relevant engineering degree 5+ years of quality engineering and/or R&D experience within medical device Experience applying ISO 14971, IEC 60601-1 and related standards to product design &

development Catheter and RF electromechanical systems experience preferred CQA, CQE certification preferred

I have detailed descriptions of the roles if you would like to take a look. Please let me know and I will send those along to you. You are welcome to share this with others that may want to take a look

******************************************************************** To apply: Visit http://tinyurl.com/chev9wj or www.BMRN.com Lab Systems Architect BioMarin - Novato, CA (San Francisco Bay Area) Job Description SUMMARY Responsible for design, deployment, and support of Laboratory Systems within the IT Enterprise Architecture Team. Works closely with various IT teams, Analysts, Lab users, and

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Vendors to assess requirements, design, procure, and implement Laboratory Computer Systems. Strong emphasis on documentation and change control in accordance with maintaining systems in a regulated environment. Researches and makes recommendations regarding hardware, software and services by analyzing vendor proposals. Administers and maintains systems by ensuring that software and hardware are maintained at levels appropriate for critical laboratory processes. Works closely with multiple teams to assure systems are qualified via proper documentation and follows established change control. This position requires knowledge in a variety of Lab applications, operating systems, network architecture, and database environments. RESPONSIBILITIES

Architect and deploy enterprise Lab applications for internal customers. Identify and recommend technical solutions for a variety of Laboratory Applications. Ensures project implementation occurs in accordance with established change control

procedures. Apply knowledge and experience to understand business challenges and opportunities

and drive new and innovative approaches to resolving them Lead and participate in technical requirements gathering and solution design sessions

with customers, partners and other technical resources of all levels. Lead and participate in project teams comprised of customers, partners, and peers as a

technical subject matter expert. Works closely with Business Analyst team and Internal IT groups to facilitate issue

resolutions. Deliver product, technology and/or solution presentations to technical and business

decision makers and engage audiences or various levels interactively. Support ongoing Production and non-production application environments, and projects.

Management of critical systems / systems processes and problem resolution /escalations of data networking and system management issues.

Measure / monitor metrics for lab applications and support processes. Research and test emerging technologies to improve delivery and efficiency in

accordance with IT Enterprise Strategy. Provides escalated technical and production support on an on-call basis.

To apply: Visit http://tinyurl.com/chev9wj or www.BMRN.com Desired Skills & Experience EDUCATION

BS/BA in related field or equivalent work experience. Industry certifications including MCITP, ITIL, PMP, and others are a plus.

EXPERIENCE 3-5 years related experience in designing, building and supporting lab systems in a

customer facing, lead role. Demonstrated ability to implement/upgrade/maintain systems within a rigorous change

control environment. Experience implementing enterprise solutions in a lab environment from inception to

release is preferred. Experience with the following applications: Lonza MODA, Labware LIMS, Watson LIMS,

SQL*LIMS, E-Lab Notebook, Empower, SoftMax Pro, Chemstation, WinKQCL, and other lab application related software.

Familiarity with scientific instruments such as Plate Readers, HPLC/UPLC’s, KQCL’s, Chromotography Skids, Microscopes, PA’s, CE’s, UV’s, Mass Spec’s, and other industry standard instruments.

Experience working with MS SQL and Oracle database environments is strongly preferred.

Experience with application and desktop deployment tools is preferred.

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Experience working in an FDA or other regulated environment with validated systems is required.

Ability to demonstrate technical expertise on various scales IT projects. Experience with application performance monitoring techniques, methods and metrics is

a plus. Troubleshooting and problem solving expertise and actions to take with other cross-

functional teams (Infrastructure, Database, Application Engineers, Business Analysts) to resolve and tune Is required.

Experience with assessing and/or implementing business continuity plans related to 24/7 software systems is preferred.

Experience supporting software systems, servers, and networks within a biotech or pharmaceutical facility Is preferred.

Familiar with industry standard best practice SDLC processes and system design documentation.

Strong technical writing and verbal (presentation) skills. Ability to create complex technical diagrams using visio. Excellent communication and collaboration skills. A successful candidate must have a strong desire to work hard, improve their skills, and

broaden the scope of their role within the organization. Candidate must be a strong team player recognizing personal improvement and awards

are best achieved by making those around you successful. To apply: Visit http://tinyurl.com/chev9wj or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. EEO/M/F/D/V Additional Information Posted: September 21, 2012 Type: Full-time Experience: Mid-Senior level Functions: Information Technology Industries: Biotechnology Job ID: 3795834 ************************************************************************

A detailed job description is available for interested candidates. Relocation will be provided. Interested candidates can contact Nancy Symonds,President, NJS Recruiting Services:

10/1/2012 41

njs@nancysymonds.com. Please send resumes as a Word.doc.

QUALITY CONTROL, SR. DIRECTOR/DIRECTOR - S. CALIF.

Our client, located in Southern California, is a contract manufacturing organization (CMO) and a wholly owned subsidiary of a biotech company focusing on the development of oncology and infectious disease therapeutics. The facility has been designed specifically for the manufacture of monoclonal antibodies and therapeutic proteins for both clinical and commercial product. They currently have a key leadership position open in QUALITY CONTROL. This individual will provide QC leadership for both the CMO and drug development arms of the Company. You will manage multiple labs with 20-25 staff. We are looking for a strong lab manager with a business orientation, strength in analytical and biologics experience, preferably with products derived from mammalian cell culture. Thank you for passing this info along to colleagues you know in Quality Control. We are always grateful for your referrals.

*****************************************************************

Scott Bailey Ocean Medical, Inc. (904) 237-2407 Scott@OceanMedical.Net Skype: scottbailey8 www.LinkedIn.com/in/ScottBailey8

Director Engineering and a Director New Product Introduction for a global, US-based medical device company. We are currently searching for a Director Engineering and a Director New Product Introduction for a global, US-based medical device company. This Corporate and US Manufacturing site (Franchise Headquarters), along with overseas manufacturing, has created two new roles: - Director Engineering (Director Franchise Operations Development Engineering and Process Capability) - Director NPI (Director New Product Introduction Operations Readiness and Integration) These critical and highly visible roles take into account many aspects of career development, including succession planning, and report into the Worldwide VP Franchise Operations. Working with the highest levels of the Corporation and interaction with the Global Management Board, these Strategic Leaders will cover New Product Introduction Engineering and New Product Introduction Operations capabilities including: Director Engineering: develop new and improve current product process capabilities for overall

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business growth. This Technical Professional will mentor, lead, and guide the efforts of Fellows, Managers, Senior Managers, and Directors in all stages of new product introduction including process development engineering, design transfer, hi-speed automated equipment capabilities (engineering, installing, validating, debugging, and optimizing), and packaging for final global product launch. Director NPI: entrusted with the stewardship and accountability for the Supply Chain, and all new product introductions and launches within the Franchise. This Development and Operational Professional will mentor, lead, and guide a team of PhD level Analysts, Project Leaders, and Managers that oversee all aspects of cost-efficient technology transfer, global launch, and supply sustainability within the Franchise product portfolio. This will include the integration of all product introduction activities to ensure that all aspects of bringing a new product to commercialization are addressed within the Supply Chain (supplier qualifications, Supply Chain readiness, site selection), and technology transfer through global product launch, from napkin sketch concept to full and long term scale-up production. For both roles, demonstrated professional strengths in communication, leadership, coordination, collaboration, partnering, global thinking, strategic thinking, project management, process orientation, and succession planning are essential. Your current title is likely to be Director R&D, Director Operations, Director Engineering, Director Process Engineering, Director (Equipment) Product Development, Director New Product Introduction and Supply Chain, Senior Director, or VP. Your product experience with hi-speed, automated, capital equipment and associated medical device disposables (perhaps monomer, polymer, silicon, rubber, or packaging) would be considered a valuable asset to the company. There are Numerous additional details that make these Exceptional Opportunities. If you are at all open, this would be the time to follow through.

*********************************************************************

Jobs that Crossed My Desk throught Sept 16, 2012 ***************************************************************** Interested parties should send resume to JBukar@JGBBioPharma.com.

Clinical Site Contract & Budget Coordinator - Contract to Full Time (San Francisco Bay area) PPBI

To view this position and other current positions please visit www.JGBBioPharma.com. No Work Visa sponsorship is available for this job. DESCRIPTION: • Will be a member of the Clinical Contracts and Outsourcing Team. • Assist team members in the drafting, negotiation and administration of non-disclosure, and

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clinical trial agreements. • Responsible for the workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for execution by corporate officers and perform other duties as assigned by the team members. • Position reports to the Sr. Director, Clinical Contracting and Outsourcing, with a dotted line reporting to the Manager, Clinical Site Contracts and Budget. Duties include, but are not limited to: • Draft, negotiate and track status of clinical trial agreements, amendments, and confidentiality agreements • Update the relevant parties regarding outstanding agreements and budgets, and provide weekly updates to clinical team • Process all agreements for execution, ensuring that the appropriate departments within receives a copy • Gather and confirm facts necessary to initiate contract formation with Legal team and internal stakeholders • Perform initial review of contracts and comments from outside parties • Negotiation with outside parties • Prepare/format and finalize contracts for execution • Prepare site budget templates • Perform budget analysis • Work with Legal team to administer a document-tracking database • Monitor contracts for compliance with company and department policies • Liaise with legal for review of contract language • Establish, draft and train with respect to process documents EXPERIENCE AND QUALIFICATIONS: • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience • 2 years of contract negotiation experience preferred • 2 years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company preferred • Understanding of the full clinical development process is desirable. • Excellent negotiation and written/verbal communication skills. This position works directly with the hospital site investigators so strong negotiation skills along with tact and excellent soft skills are required. • Ability to work independently, creative thinking and problem solving skills • Ability to understand the full clinical development process • Must have good organization and planning skills, proven ability to handle multiple priorities and work independently • Excellent Excel skills and Proficiency with MS Word, Access and Outlook required • A clinical focus is strongly preferred. Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com

Clinical and Clinically Related Jobs jgbbiopharma.com

All open positions are not posted. To be considered for a position, send your resume or an email inquiry to Jobs@JGBBioPharma.com. Duties include, but are not limited to: EXPERIENCE AND QUALIFICATIONS: To apply for a position...

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_______________________________________________________

Interested parties should contact and send resume to Vivian@JGBBioPharma.com.

Senior Project Manager – Full Time Position (San Francisco Bay area) PPBI

To view this position and other current positions please visit www.JGBBioPharma.com. No Work Visa sponsorship is available for this job. DESCRIPTION: Support cross-functional project teams to design and execute drug development plans for our lead drug and our partnership. Reports to the Executive Director, Alliance and Project Management. • Facilitate and coordinate cross-functional projects within the company and with external partners and collaborators. • Organize meetings, prepare agendas, accurately record minutes and action items of all scheduled and ad hoc project team meetings, and distribute to team members and management in a timely manner. • Independently and proactively follow up on action items. • Independently and proactively identify potential issues and manage resolution across functional areas. • Communicate project progress at team meetings and in status reports. • Help make objective team recommendations to management for continuation, acceleration, prioritization, or termination of projects. • Develop and maintain chart timelines for projects and oversee, track, and document team member task completion to ensure that timelines are met. • Help project teams define and establish project goals and go/no-go criteria, create and manage project plans, and participate in data-driven decision-making to allow progression of clinical development. • Schedule and facilitate ad hoc meetings of the project team and sub-teams to address issues outside of regularly scheduled project team meetings. EXPERIENCE AND QUALIFICATIONS: • B.A. or equivalent in a scientific discipline and at least 10 years related project management biopharma experience or advanced degree with less related experience. • Strength in the CMC area or a generalist is preferred as this position will be ~ 50% in the CMC area, The rest will be research, clinical and other function. • Thorough working knowledge of Gantt charts and MS Project. • Excellent written and verbal communication skills. • Proven ability to make independent judgments regarding approaches to cross-functional collaboration internally and with partners. • Demonstrated success in working proactively and managing relationships in a positive, team-oriented, and constructive manner. • Highly skilled at providing feedback and constructive approaches to solving technical and people problems. • Working knowledge of all phases of pharmaceutical product development through clinical commercial launch is desired. • Experience applying GXP principles and FDA/ICH guidelines is essential. Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com

Project Management Jobs jgbbiopharma.com

Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good...

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Ken Nunley, Principal at 7SolutionsUSA Submit resume to Ken@7SolutionsUSA.com

California Senior Director Global Supply Chain Location: San Diego… CA Salary: $180,000.00 - $220,000.00 Job ID: 01842102

Must be a pharmaceutical, biological subject matter expert. Must be a Global Supply Chain subject matter expert.

********************************************************************* Contact For consideration please submit your resume to http://www.perkinelmer.com/ourcompany/careers/careeropportunities/default.xhtml If you know of someone who would be a good fit for the positions listed below, feel free to forward them this information. Olga Campa, SPHR | Human Resources Senior HR Manager/HR Business Partner Caliper - a PerkinElmer Company | Life Sciences & Technology 2061 Challenger Drive | Alameda | CA 94501 | United States Office: 510-291-6155 olga.campa@perkinelmer.com Caliper, a PerkinElmer company is a leading provider of cutting-edge technologies enabling researchers in the life sciences to create life-saving and enhancing medicines and diagnostic tests more quickly and efficiently. Caliper has compiled numerous best-in-class solutions and is aggressively innovating new technologies to bridge the gaps that exist in bringing in vitro assays to in vivo results and ultimately into cures for human disease. With a keen focus on clinically-relevant experimentation, Caliper’s portfolio of offerings includes state-of-the-art microfluidics, lab automation & liquid handling, optical imaging technologies, and discovery & development outsourcing solutions. Our company represents a community of intelligent, highly-motivated people dedicated to working together as a team to improve the human condition through innovation in life sciences research. Caliper’s customers and partners include leading pharmaceutical companies like Pfizer, GlaxoSmithKline, Sanofi-Aventis, Novartis, and AstraZeneca, among others. If you are committed to making a significant difference worldwide, we invite you to learn more about the amazing opportunities that await you at PerkinElmer. Associate Product Manager, Preclinical Imaging (4305): Alameda, CA We are recruiting for the following regular full-time job opportunity as an Associate Product Manager, Preclinical Imaging. If you would like to learn more about this position, please see our PerkinElmer Careers Page, search for North America, then Associate Product Manager, Preclinical Imaging (Job Code 4305). All applicants must apply online for consideration. Our LST group is seeking an associate Preclinical Imaging Product Manager to be responsible for the day-to-day support of the Imaging Product portfolio, in development and in the market. Responsibilities: • Conduct market research on new product opportunities

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• Providing a thorough understanding of product line dynamics and opportunities for strategic planning • Devise and implement tactical marketing strategies to expand market adoption of product line • Assumes ownership for working with appropriate groups to resolve issues as needed • Participate within a multidisciplinary team supporting new product development • Develop sales tools and supporting collateral to aid the efforts of the global sales force • Work with online portals to maintain product content and online exposure • Develop lead mining and targeted marketing campaigns • Serve as the product champion, ensuring product performance meets expectations and explore ways for continuous improvement and market adoption • Coordinate application content for field and marketing channels with the Biology team and Engineers • Work closely with Marketing Communications to develop event, trade show and advertisement focus and messaging • Contribute to corporate marketing goals and revenue targets by actively supporting the sales team through lead generation and visits/presentations to customers Qualifications: • Must have a minimum of 2-4 years’ experience in similar position, preferably in life sciences of pharmaceutical product management role • Proven track record of results either contributing to or directly developing, driving and maintaining high performing product lines, cutting edge strategies and strong market presence • Demonstrated experience in establishing relationship with key thought leaders and with internal organizations • Excellent communication and strong writing skills • Ability for up to 25% travel • Bachelor’s Degree, PhD in the Biological Sciences and/or MBA highly desirable. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential of the above listed essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Bachelor’s Degree, PhD in the Biological Sciences and/or MBA highly desirable. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and color vision. For consideration or to learn more information about this position and other career opportunities, go to http://www.perkinelmer.com/ourcompany/careers/careeropportunities/default.xhtml

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About Us As a global technology leader, PerkinElmer is taking action to harness the power of insights and transform them into knowledge to deliver innovative, differentiated solutions for our customers. From critical therapeutic and disease research and prenatal screening, to environmental testing and industrial monitoring, we are actively engaged in improving health and advancing quality and longevity of life all around the world. From multi-vendor laboratory services, software and informatics, to clinical lab testing and unparalleled customer care; we have the people, tools and resources to help customers solve their business and scientific goals. Our core competencies, coupled with our commitment to excellence, provide a strong foundation for delivering optimal service and support. By encouraging exploration, ingenuity and integrity, together with teamwork and employee development, at PerkinElmer we live our mission, every day. If you have an interest in becoming a part of a fast growing, innovative company and possess the skills to excel in the position posted, please submit your resume at http://www.perkinelmer.com/ourcompany/careers/careeropportunities/default.xhtml. To learn more about this or other career opportunities and/or to learn more about the possibilities with PerkinElmer go to: www.perkinelmer.com. If you have an interest in becoming a part of a fast growing innovative company and possess the skills to excel in the position apply today! *********************************************************************** Contact Eric Andrew Morse, Scientific Recruiter at R&D Partners, at http://bull.hn/l/RX13/2 Now Hiring! A large, multinational biopharma company has an immediate hire for a Manufacturing Specialist! Job: Manufacturing Specialist in Emeryville, CA Job Description: The Specialist/Sr. Specialist, Technical Services, provides technical support for production operations in the Technical Services area (reagents and glassware). This includes, but it is not limited to assisting with manufacturing operations, providing expertise on technical troubleshooting, supporting process and equipment validation, writing and revising SOPs, implementing change control and process improvement projects, participating on and owning discrepancy investigation (DRs) and drive completion of associated corrective and preventive actions (CAPAs). The Specialist/Sr. Specialist may also serve as back up to the Technical Services production manager. Responsibilities: · Manufacturing support – assists in the development and execution of commissioning and validation activities; create and revise Manufacturing procedures; train Technical Services staff on critical process and equipment changes; reviews and approves Manufacturing Production Records and acts as back up to the Technical Services production manager. · Deviation management – investigates manufacturing deviations and implements corrective actions. Partners with functional owners from other areas to ensure completion of cross-functional corrective actions. · Change management – initiates and completes change control to continuously improve manufacturing processes, equipment and Facility. · Development support – serves as a go-between with the Technology Development department; acts as a Technical Services subject matter expert for continuous improvement efforts and new processes. · Engineering support – serves as a go-between with the Engineering department; act as a

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Technical Services subject matter expert for facility/equipment improvement efforts and new capital projects. · Project management – assists area management and PM department with cross-functional projects (capital and non-capital). Education Requirements: -Must have experience in GMP manufacturing, minimum 5 years. -Must have a bachelor’s degree on science/engineering related subject. -Must have experience in FDA and ISO regulated environments. -Must have adequate knowledge of Reagent, glassware cleaning and processing operations. -Must be proficient with word processing, spreadsheets, database management and presentations. -Experience with FMEA and Risk Assessment methods is desired -Experience with lean manufacturing, statistical analysis and project management are desired. ******************************************************************** Contact Eric Andrew Morse, Scientific Recruiter at R&D Partners, at http://bull.hn/l/RXBW/3 Immediate hire for a QA Specialist at a SoCal Biopharma company! Hiring a QA Specialist in Thousand Oaks, CA Description: A major pharmaceutical company is seeking an experienced professional to support its GMP operations. The incumbent will perform a wide variety of activities to ensure compliance with applicable GXP requirements. Responsibilities include: Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operations. Writes and revises standard operation procedures. Conduct investigations related to manufactured products. Generates reports. Applies knowledge of good manufacturing practices on a daily basis. Participates in the disposition of batches, including resolution of investigations and deviations to meet lot release time lines and disposition as designated. Maintains the cross project support systems which may include, material receipt, QA line clearance, area approval, packaging inspection, batch record review, device assembly audit and release and verification of supply shipments with minimal management oversight. Participates in quality investigations utilizing QA tools and follows up on corrective actions to closeout. Reviews data audits and report reviews as required. Provides support to other projects as assigned. Requirements: A Bachelors degree in a scientific discipline is recommended. A minimum of 2 years related experience. Experience with QA systems. Strong oral and written communication skills are required. Must have excellent interpersonal skills. A knowledge of FDA regulations and cGMPs for drugs and device are a must. Computer literacy (MS Word, Excel) _____________________________________________________________

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Contact Eric Andrew Morse http://bull.hn/l/RWDW/6 Immediate hire for an Analytical Scientist in Emeryville, CA! Are you a good fit for this job? Analytical Scientist, Methods Validation in Emeryville, CA Analytical Scientist, Methods Validation Job Description: Responsible for developing and validating release, in-process and cleaning methods in support of Novartis Diagnostic’s immunodiagnostic products. This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods’ intended use(s) and comply with applicable regulatory and company validation requirements. Responsibilities: · Develop and validate analytical test methods for immunodiagnostic products and intermediates in accordance with ICH/USP requirements and Novartis Quality Module guidelines · Write analytical method validation protocols, method validation summary reports, and method development reports · Train and provide technical assistance to fellow QC Methods Validation and QC Chemistry team members · Review method development and validation data to ensure completeness and accuracy · Evaluate existing analytical method validation packages for accuracy and compliance with current ICH and Novartis Quality Module guidelines · Develop and maintain validation project plans and their associated timelines · Perform deviation investigations and CAPA implementation in support of method validation projects · Assist technical operations staff in development and evaluation of appropriate method validation acceptance criteria · Assist Quality Control department management during inspections/audits (regulatory or internal) and audit observation responses Experience Requirements: -10 years in a GMP environment (Pharmaceutical or Diagnostics/Device industries) with at least 5 years in analytical method validation -Highly experienced in executing analytical test method validation -Experienced in protein chemistry and immunochemistry methods such as SDS-PAGE, ELISA, reversed phase and size exclusion chromatography, absorbance assays, and Western Blots -Excellent written and communication skills, scientific report writing -Proficiency in MS Word and Excel. -Proficiency in other statistical analysis software desired. Education Requirements: -Bachelors degree in Chemistry, Biology, or a related field *************************************************************************** Contact is Paula at paula@legacymedsearch.com See list of open positions in Medtech athttp://legacymedsearch.com/refresh/templates/careers.php?id=9&utm_source=Copy+of+September+2012+Newsletter&utm_campaign=September+2012+Newsletter&utm_medium=email Some examples include: Risk Management Engineer - NY

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Adverse Event Analyst - NY Quality System Manager - NY Complaint Analyst - NY QMS Coordinator - NY Account Manager - Capital Device - FL Director of Marketing - Medical Device - TX Technical Support Engineer - Southeast Regulatory Affairs Manager - Medical Device - NY Quality Manager - Medical Device Drug Delivery - NY General Manager - Dental - WI Marketing Manager - Capital Equipment - CA Chief Executive Officer - NC Principal Software Engineer - MA Marketing Manager - Robotic Medical Device - MA President & CEO of Medical Imaging Multi-Facility Practice Administration - FL Clinical Specialist - Spine - MD Access full list of positions at Legacy’s website at http://legacymedsearch.com/refresh/templates/careers.php?id=9&utm_source=Copy+of+September+2012+Newsletter&utm_campaign=September+2012+Newsletter&utm_medium=email *********************************************************** Quality Engineer III, Pharmaceuticals (Direct Hire) Lab Support, a division of On Assignment - Orange County, CA (Orange County, California Area) Job Description We are recruiting for our client, a top global pharmaceutical company that is seeking a Quality Systems Engineer III to join their winning team. Summary This position will be responsible for reviewing or approving the validation of product, equipment, process, and laboratory equipment and or QC methods. Provides Quality Assurance oversight to facilities, maintenance, engineering and/or QC laboratories. The QE III will have the ability to collect data, analyze, and identify the most important parameter affecting product quality and will implement preventive/corrective action plans (root cause analysis); as it relates to a variance, complaint, and OOS investigation. Using job knowledge and skills, the individual ensures compliance to company standards and regulatory guidelines. The QE III will provide quality support to facility maintenance, engineering, and validation personnel. As a QE III, it is expected the individual can work independently with minimal guidance, has advanced knowledge & skills in quality systems, and is a group facilitator and can assume a leadership position, if required. Duties and Responsibilities • Review / analyze data and initiate problem solving, corrective and preventive actions to resolve issue. Drive closure of issues with responsible individuals and departments. • Provides technical assistance on a multitude of issues, such as OOS investigations, review of SOPs, approves equipment/facility validations, provide project support and resolve quality issues. Assist with the recommissioning of the plant facilities and critical utilities. • Develop & implement improvements of processes and standardization of Quality systems. Lead / Participate in Quality improvement initiatives. • Informs management through written and verbal communications of Compliance issues, while identifying findings, observations, and potential corrective actions. Writes reports regarding non-conformances, corrective/preventive actions, and improvement initiatives • Integral participant with inspections/audits by Regulatory agencies and Contract Manufacturing customers.

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• Represent the Quality System Manager at meetings or emergency events. • Ensure investigations met all regulatory requirements and allow the timely release and delivery of products. • Provide a detailed and comprehensive report with a recommendation and final conclusion. To effectively communicate to other department personnel, as well as outside contract customers, regarding any issues or resolutions. Desired Skills & Experience Requirements • Bachelors degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent related industry experience • A minimum of 8-years experience in the pharmaceutical or related industry • Experience preferred: • Laboratory management experience • cGMP Manufacturing experience • Experience in laboratory method development and validation • Experience with HPLC and other laboratory instrumentation Technical Knowledge: • Formal auditing experience • Excellent interpersonal and communications skills required • Strong organizational and technical writing skills required • Thorough knowledege of Method Validation Guidances, risk management, and root cause analysis. • Knowledge of regulatory requirements, such as 21 CFR 210 & 211 • Computer literacy required, includes Microsoft Word, Excel, and Access Company Description Lab Support, a division of On Assignment, is an international leader in placing scientific and engineering professionals in contract, contract-to-hire, and direct hire opportunities. Having pioneered a specialized staffing approach, most Lab Support Staffing Consultants possess a degree in science or engineering and a passion for the industry they represent. With over 25 years of experience, we successfully place professionals in industries such as biotechnology, medical device, pharmaceutical, food and beverage, environmental, chemical, and consumer care as well as government and academia. Lab Support has locations throughout the United States, United Kingdom, Netherlands, Belgium, and Canada. Please click here to view detailed map: http://www.oalabsupport.com/oalab/locations/mainLocations.html Additional Information Posted: August 28, 2012 Type: Full-time Experience: Mid-Senior level Functions: Science, Engineering Industries: Pharmaceuticals Job ID: 3640489 *********************************************************** Apply online at website http://www.stjosephhealth.org/Careers.aspx Area Director of Pharmacy St. Joseph Health System-Sonoma County - Santa Rosa, CA (San Francisco Bay Area) Job Description The Area Director of Pharmacy is responsible for managing the Pharmacy Departments at Santa Rosa Memorial Hospital and Petaluma Valley Hospital. The Area Wide Pharmacy Director will embrace and articulate the mission, vision, values and goals of the St. Joseph Health System-Sonoma County to create a culture of trust excellence and shared purpose.

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The Area Director of Pharmacy reports directly to the Chief Executive Officer for the service area. The Director will have 41.5 FTE direct reports (35 FTEs at Santa Rosa Memorial Hospital and 6.5 FTEs at Petaluma Valley Hospital). Essential Duties and Responsibilities: The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all inclusive:

Champion a culture of patient safety Optimization of the pharmacy system and CPOE Continue to improve and implement Medication Error Reporting Program Improve department efficiencies and help reconcile the budget with necessary

resources Implement nursing/pharmacy workflow best practices across the service area Participate and champion medication safety initiatives. Actively champion process improvements through lean methodologies Lead formulary and drug utilization initiatives and engage physicians around clinical

best practices Identify pharmacy Integrated Delivery System medication management initiatives that

improve medication management beyond the acute care setting. Continue strong team building and mentoring for the pharmacy department service Assures that organizational and department policies and procedures are current,

appropriate, meets regulatory requirements and followed consistently Desired Skills & Experience Candidate Qualifications:

5 – 7 years recent experience in acute hospital setting 2 – 4 years management experience Excellent communication skills, advanced knowledge of job specific skills and computer

proficiency. Flexibility to prioritize multiple projects and work time as required. Highly collaborative individual with ability to influence others and build strong

professional relationships. Proficient with computer tools, specifically in Microsoft Word, Excel, Power Point,

Outlook, Microsoft Project A strong commitment to St. Joseph Health System’s Mission & Core Values

Education: Graduate of an accredited School of Pharmacy; PharmD Preferred Current California Pharmacist License or commitment to obtain within 18 to 24 months.

Company Description St. Joseph Health System (SJHS) is an integrated health care delivery system providing a broad range of medical services. The system is organized into three regions -- Northern California, Southern California, and West Texas/Eastern New Mexico -- and consists of 14 acute care hospitals, three home health agencies and multiple physician groups. The facilities that comprise the Health System offer a wide variety of services within each of the three regions. From well-established acute care hospitals to clinics in non-traditional settings like school rooms and shopping malls, SJHS is establishing a "continuum of care," that is, a system that links and coordinates an entire spectrum of health services. SJHS is an industry leader in providing quality care. All of its hospitals and home health entities are accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). St. Joseph Health System-Sonoma County Additional Information Posted: September 17, 2012 Type: Full-time Experience: Director Functions: Management Industries: Hospital & Health Care

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Compensation: Base-$180K-$200K+Bonus-0-15%+Relocation Job ID: 3763508 **************************************************************

Contact: Brian Seleyo Phone Number: 215.656.2613 Email Address: brian.seleyo@yoh.com

HIRING: Clinical Manufacturing Engineer Support (Validation) – Berkeley, CA

Position: Clinical Manufacturing Engineer Support (Validation) – Berkeley, CA Location: Berkley, CA Pay Rate: Based on Experience Job Responsibilities: Position Purpose Supports clinical manufacturing by providing engineering support for process equipment, facilities and utilities. Major Tasks and Responsibilities: • Applies Engineering fundamentals in equipment design and problem solving • Applies knowledge of GMP requirements to practice in clinical manufacturing • Ensures reliability of clinical manufacturing equipment, facilities and utilities • Ensure equipment and utilities required for manufacturing uptime through preventive or predictive measures, modifications and repairs • Provides the necessary technical expertise for troubleshooting and resolving problems with equipment and utilities • Support our clients Berkeley’s facilities commitment to safety by complying with the programs regarding health, safety and protection of the environment • Manages projects with understanding of event sequencing and level of effort required to complete projects on time • Recommends new and innovative solutions to problems utilizing high degree of scientific development creativity, independent thought and proficiency • Interface with maintenance for PM/calibration/repairs of GMP equipment and utilities • Create new and/or revises existing SOPs for process skid, bioreactors, support equipment and utilities • Complete validation activities including, authoring protocols, installation and operational commissioning and qualification testing of equipment and systems • Fosters team based approach to clinical manufacturing Minimum Requirements: Bachelor’s degree in Chemical, Mechanical or Electrical Engineering with a minimum of 8 years relevant experience Master’s degree in Chemical, Mechanical or Electrical Engineering with a minimum of 6 years relevant experience • Experience with regulatory and cGMP requirements for pharmaceutical manufacturing • Familiarity with standard biopharmaceutical equipment/processes, including bioreactors, chromatography skids, UF/DF and TFF • Demonstrated ability to independently troubleshoot problems requiring original thought. • Understands how GMP requirements are applied to practice from development to clinical

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manufacturing • Experience with process control/monitoring systems, such as, BAS, SCADA, DCS, PLC low voltage electrical systems • Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities and facilities, WFI systems, HVAC, process instrumentation and control systems • Experience with FAT, SAT, commission and qualification including hands-on experience starting-up and running new equipment and developing turn-over packages • Excellent verbal and written communication skills • Good working knowledge of Microsoft Software (Word, Excel)

********************************************* Apply on company website at www.Veevasystems.com HR Director Veeva Systems - San Francisco Bay Area Job Description Are you looking for a fast-paced successful start-up where you can make an impact and grow your career? Veeva Systems, recently recognized as the leading CRM vendor in the Pharma/Life Sciences space by IDC, may be the place for you. We are a rapidly growing SaaS pre-IPO company that has 350+ employees across the globe, with material presence in Europe, China and Japan supplementing our East Bay HQ’s. . We are looking for a seasoned, business-savvy HR leader to take the HR function to the next level and make sure that Veeva remains a cool place to work. This position manages a growing team of four and will be leading the charge to build the most effective, creative and efficient HR function possible. . Responsibilities: The Director of Human Resources is responsible for developing key HR-organizational partnerships with management and fostering an employee-oriented culture that emphasizes quality and innovation. The position is responsible for leading all global HR activities, including: recruitment, on-boarding, employee relations, compensation and benefits, compliance, HRIS and training. The ideal candidate is hands-on, flexible, confident and possesses business acumen with the ability to link HR programs to financial success. . Some key responsibilities of our Director of HR will include:

Ensuring that HR priorities are in alignment with the business needs of Veeva; Evolving HR processes to support scalable growth to a 1,000+ person organization Developing practices and programs that attract, retain and develop the best possible

talent in the marketplace and makes the company attractive to them through competitive pay and an engaging culture;

Creating and enhancing unique and successful on-boarding techniques; Bringing expert advice and tact in resolving employee relations issues; Monitoring the company’s cultural environment and proactively addressing issues when

possible; Ensuring that the company is compliant with all current human resource related laws,

regulations and administrative rulings of governmental organizations worldwide; Working collaboratively with the CFO and CEO to create compensation and benefits

programs that are competitive, consistent with the Veeva's culture, cost effective and align individual performance with company success;

Owning the process to determine the appropriate HRIS system for Veeva and manage the implementation;

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Leading and mentoring the global HR team to build the most effective, creative and efficient HR function possible.

Desired Skills & Experience Requirements:

10 to 14 years’ experience in HR, with 3-5 years in a senior role (HR Sr. Manager or above)

Global human resources experience Proven leader who can build a strong individual brand and credibly drive change in the

organization Demonstrated success in leading a high caliber team Strong work ethic, willing to get the job done and see a task/project to completion Client service orientation with excellent communications skills Bachelor’s degree in HR or similar degree.

Nice to Have: Experience in a technology company, specifically SW or SaaS company Experience in a public company or being in a key role while going public MBA or other advanced degree

Company Description Veeva Systems is the leader in business solutions for the global life sciences industry. We’re rapidly growing, profitable, with over 150+ customers and 300+ employees worldwide. Our product teams are based mostly in Pleasanton, CA and San Francisco, CA. Veeva was named to the Red Herring 'Top 100' software companies in 2011. Founded in 2007, Veeva is a privately-held company headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Beijing, Shanghai, and Tokyo. For more information, visit www.veevasystems.com Additional Information Posted: September 17, 2012 Type: Full-time Experience: Mid-Senior level Functions: Human Resources Industries: Computer Software, Pharmaceuticals Job ID: 3765444 ********************************************** Contact: Jim Deavours jimd@fpccareers.com Search Jobs: Results: Senior Principal Engineer / Biopharmaceuticals - Aseptic Fill / Finish Industry leader in the Pharmaceutical and Biopharmaceutical Industry seeks Senior Principal Engineer to lead and support projects for Aseptic Fill / Finish and Lyophilization at an expanding manufacturing site. As the Subject Matter Expert, the Senior Principal Engineer will be responsible for the design, selection, start-up and commissioning of Aseptic Fill / Finish and Lyophilization lines and equipment. He / she will also be responsible for equipment improvement and problem resolutions regarding Fill / Finish and Freeze Drying as well as managing shut down, equipment replacement and start up operations. The ideal candidate will possess a B.S. in Engineering, experience managing capital projects for Aseptic Fill / Finish in GMP / Pharmaceutical manufacturing and demonstrated expertise in supporting related equipment and processes. The Senior Principal Engineer will be a self-starter with the ability to take charge and thrive in a fast-paced environment. The company provides a success oriented work environment with highly competitive compensation and benefits. *****************************************************************

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To apply for a position send your resume to Margaret @JGBBioPharma.com Seeking CRAs to Senior Program Manager - San Francisco Bay Area PPBI To view current job descriptions please visit www.JGBBioPharma.com. Interested parties should contact Margaret@JGBBioPharma.com. We are seeking to fill Clin Ops positions for our clients No Work Visa sponsorship is available. Some clients offer basic relocation. Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Clinical and Clinically Related Jobs jgbbiopharma.com All open positions are not posted. To be considered for a position, send your resume or an email inquiry to Jobs@JGBBioPharma.com. Clinical Program Manager to manage multiple clinical trials. EXPERIENCE AND QUALIFICATIONS: To... **************************************************************** Charley Lyons, Sales and Recruiting Manager for the Compass Consulting Group Send resumes to: Charley Lyons at clyons@compasscgroup.com LA based BioPharma Market Researchers needed - Primary & Secondary Data Analytics consulting projects We have two full-time and one part-time (20-30 hours per week) consulting needs for a biotech client based in Ventura County. Market Researchers with direct Biotech/Pharma experience please send your resume to clyons@compasscgroup.com or message me directly. Overview of our needs: Primary market researcher - strong primary experience including global primary research , both quantitative and qualitative methodologies, and early stage molecule experience a plus. Secondary data analysis - Qualifications include ability to translate a business issue/question into an analytical plan, strong Excel skills, SAS skills, highly analytical. ***************************************************** To apply: Email resumes to staffmail2@stafficons.com Multiple CLS Openings in California! Staff Icons is currently seeking CLS candidates for ALL laboratory departments!! Position: Clinical Laboratory Scientist (All levels/departments available) Location: Southern Orange County, CA Schedule: Full Time/Permanent- All shifts available *MUST have CA CLS license in place *************************************************** See listings and access at http://www.linkedin.com/company/1012623?trk=jobtocomp Associate Director Document Control Real Staffing Group - South San Francisco, CA (San Francisco Bay Area) Job Description Associate Director, Document Control A pharmaceutical company in the South San Francisco area is looking for an Associate Director, Document Control to join their team. The company is in the process of refining their systems. The Assocaite Director Document Control will be responsible for restructuring their SOP program.

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Desired Skills & Experience Associate Director, Document Control

5+ years experience in the Pharmaceutical industry The ideal candidate needs to be an expert in SOP overhaul Experience revamping Doc Control and SOP systems Experience working cross functionally with international sites or within a global

company This is an excellent opportunity to join a growing organization with an exciting pipeline! Please respond to this job positing ASAP to be considered. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted: September 12, 2012 Type: Full-time Experience: Director Functions: Quality Assurance, Consulting, Other Industries: Pharmaceuticals, Biotechnology Job ID: 3739389 ************************************************** Please apply online at www.pharmacyclics.com. About Pharmacyclics Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Job Description: Senior QA Specialist Job Summary: Performs and maintains QA programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical drug

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substances and drug products manufactured at CMOs. Key Accountabilities/Core Job Responsibilities:

Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug substance (API) and drug products (DP) under clinical development in compliance with US FDA and international health agency requirements.

Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.

Coordinates, leads and conducts internal Quality Investigations as well as investigations at contract manufacturing organizations (CMOs).

Performs person-in-plant (PIP) during manufacturing campaigns of API and DP at CMOs.

Reviews and approves change control requests to ensure compliance with Company procedures, cGMP, and other applicable regulations.

Represents QA and provides support to the internal CMC team. Lead compliance internal audits. Provides and prepares quality metrics as needed. Initiates updates and creation of new SOPs as required. Serves as Quality Representative for regulatory inspections as needed.

Education and Training: (degree, certifications, etc.) Minimum BA/BS Degree in biological sciences, chemistry, or related field.

Experience: 7+ years of pharmaceutical experience in a GMP quality (QA/QC) environment.

Specific Skills/Abilities Excellent working knowledge and understanding of GMP related requirements,

proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus.

Detail oriented with Quality Assurance background with solid problem solving acumen. Ability to work effectively in a team environment with great organization skills.

Excellent working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials.

Ability to analyze and reconcile moderate to complex issues independently. Must be an individual with proven initiative and demonstrated accountability in a fast

paced environment with high degree of flexibility. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e. 2007 Microsoft Office

products). Required 10% travel.

_________________________________________________________________ Job Description : Senior Clinical QA Specialist

The Clinical QA Specialist supports the Clinical Quality Assurance (CQA) management in developing its clinical quality systems and procedures. Assists in development of audit plans to ensure all trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements. Assists with CQA audits of clinical sites, quality systems, clinical vendors and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements. Assists with audit reports management and corrective action plan completion. Ensures work is carried out according to GCP standards as defined in the

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ICH Guidelines, corporate policies and procedures, and all regulatory requirements. Key Accountabilities/Core Job Responsibilities: Assists with development of CQA plans and implementation of the actions necessary

to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirement

Assists with conducting US and international sites, internal and external clinical systems and clinical vendor audits

Assists with all audits are followed-up and corrective actions are completed, implemented, and verified

Assists with investigations of GCP-related matters (i.e., product complaints) Assists with CQA quality systems and supports department infrastructure

development; assist with creation/revision of appropriate CQA SOPs Assists with GCP training activities Assists in the review of regulatory submission documents (Clinical Study Report and

Integrated Safety/Efficacy Summaries) and other essential documents (Protocol, Informed Consent Form, and Trial Master Files)

Assists in the development of metric reports to CQA management of all issues related to the outcome of the audits

Facilitates CQA team meetings and discussions as needed Education and Training: (degree, certifications, etc.) Minimum BA/BS Degree in biological sciences, chemistry, or related field Experience: 3+ years of pharmaceutical experience in a clinical development arena 1+ year direct US and international Clinical QA auditing experience Specific Skills/Abilities Must be a team player Excellent working knowledge and understanding of GCP-related requirements,

proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong clinical development background

Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skills

Ability to work effectively in a fast-paced environment with initiative and great organization skills

Excellent verbal and written communication and interpersonal skills

_________________________________________________________________ Job Description: Director/ Sr Director CMC Regulatory Affairs The Director/Sr. Director of CMC Regulatory Affairs acts as the CMC regulatory lead by providing regulatory strategy and support to global development teams and facilitating all regulatory filings relating to CMC. Key Accountabilities/Core Job Responsibilities:

Develops CMC regulatory strategy for PCI-32765 Represents RA CMC at project team meetings and coordinates regulatory workflow

between departments as well as CROs Coordinates, writes, compiles CMC document packages and investigational drug

shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs

Regulatory lead for module 3 of upcoming eCTD filings Acquires and maintains current knowledge of applicable regulatory requirements and

scientific/technical issues in the area of small molecule pharmaceuticals.

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Regulatory Lead for interactions with regulatory authorities on CMC issues. Participates in Regulatory Affairs initiatives to improve PCYC standards and systems.

Qualifications/Skills:

Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills

Proficient with computer (MS Office) and internet skills. Strong interpersonal skills and a proven ability to contribute to a team environment

involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.

Proven ability to communicate with executive management, cross-functional team members and operational staff.

Flexible attitude with respect to work assignments, and new learning. 8+ years relevant regulatory CMC experience BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent)

*************************************************************************** Contact company at http://www.wave80.com/contact/index.php Engineer I Wave 80 Biosciences, Inc. - San Francisco (San Francisco Bay Area) Job Description Responsibilities will include:

Manufacture microfluidic cartridge components using CNC micro-mills and other low-volume production tools

Participate in manufacturing process development for disposable low-cost microfluidic bioassay cartridges

Conduct and document experiments to characterize cartridge-format methods for acquiring and processing biological samples

Collaborate and communicate effectively within a cross-functional engineering team to support the development, verification, and production of novel cartridge-format clinical laboratory systems incorporating optics, microfluidics, biochemical assay techniques, and electronics

Desired Skills & Experience Required Qualifications:

BS in mechanical engineering, biomedical engineering or closely related field. Detail-oriented and highly motivated; strong prioritizing and multi-tasking skills to work

within tight deadlines; able to work independently in a fast-paced, project-driven environment

Experience using Solidworks or other CAD/CAM tools Familiarity with basic statistical methods for analyzing experimental results

Desired Qualifications: Experience with plastic part production processes including machining and injection

molding Experience developing FDA-regulated medical devices or diagnostics under design

controls Experience working with blood or other biological samples Experience using MATLAB, Labview, and/or Simulink for instrument control and data

I/O Company Description Wave 80 Biosciences develops next-generation molecular diagnostics instruments and consumables for hepatitis C, hepatitis B, HIV/AIDS, and other human health conditions.

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Distinguished by a novel one patient-one test usage model, best-in-class performance, and a superior value proposition, Wave 80’s pipeline products address unmet needs of diverse patient populations worldwide in the high-clinical-value molecular diagnostics segment of the clinical laboratory testing systems market. Wave 80 Biosciences, Inc. Additional Information Posted: September 11, 2012 Type: Full-time Experience: Entry level Functions: Engineering Industries: Medical Devices Job ID: 3728878 ************************************************************************ Strategic Account Director (West) L&M Healthcare Communications - San Francisco Bay Area Job Description The Strategic Account Director creates, maintains, and expands relationships with West Coast clients. Assigned two to four clients, the Strategic Account Director is assigned strategic account objectives and will be responsible for providing strategic leadership on accounts, and for achieving new and organic business growth. The Strategic Account Director represents the entire range of L&M services to assigned clients, while leading the client account planning cycle and ensuring assigned clients needs and expectations are met by L&M. The Strategic Account Director reports to the Chief Strategic Officer. Service

Establishes productive, professional relationships with key personnel in assigned accounts, keeping a finger on the “pulse” of the client

Enlists the involvement of L&M personnel, such as Project Management, Medical, and administrative resources, delivering on program/project objectives while meeting account performance goals and clients expectations

Strategy Acts as a trusted advisor on issues impacting the clients’ business Proactively assesses, clarifies, and validates client needs on an ongoing basis. Leads solution development efforts that best address client needs, while coordinating

the involvement of all necessary L&M personnel Sales

Identifies new business opportunities through traditional and innovative approaches Initiates joint L&M-strategic account planning process that develops mutual

performance objectives, financial targets, and critical milestones for a one and three-year period

Meets assigned targets for new/organic business growth and strategic objectives in assigned accounts

Desired Skills & Experience Four-year college degree from an accredited institution MBA-preferred but not required Minimum ten years of experience combined from agency/medical education account

management, bio/pharma product management, consulting, and new business development

This position requires extensive travel All prospective employees must pass a background check

Company Description

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L&M Healthcare Communications, is a KOL development, medical strategy & communications agency, located in Mountainside, NJ. L&M is composed of seasoned medical education agency executives, former bio-pharma manufacturer based marketers, and individuals with advanced degrees in medicine and the sciences. We are differentiated from other mid-sized agencies in that we have boutique divisions/services that address client needs through the product lifecycle.L&M Healthcare Communications L&M Healthcare Communications Additional Information Posted: September 11, 2012 Type: Full-time Experience: Director Functions: Strategy/Planning, Business Development, Management Industries: Marketing and Advertising, Biotechnology, Pharmaceuticals Job ID: 3727709 ********************************************************************** Apply on company website Director, NCI & Cooperative Group Studies Pharmacyclics - San Francisco Bay Area Job Description The Director of NCI / Co-operative Group Studies will serve as Principal investigator for Pharmacyclic’s CRADA with NCI, and liaise with CTEP’s Principal Investigator and Co-operative Groups on phase I – III studies. Responsibilities include:

Support the development of NCI-CTEP & Cooperative Group studies. Facilitate the initiation of research projects and ensure that objectives of the project are

clearly defined and within priority areas consistent with the strategic development objectives.

Responsible for the review of LOIs and protocols and successful execution of appropriate processes for review, approval, and support of studies while maintaining investigator independence according to regulatory and compliance guidelines

Desired Skills & Experience Requirements: - Seven years’ experience in the biotech or pharmaceutical industry in Medical Affairs or Clinical Research, with experience working with NCI and Cooperative Groups, and cross-functional teams. - A demonstrated capability for creative and strategic thinking. - Ability to build high level medical/scientific knowledge, and to grasp complex concepts quickly. - Proven ability in establishing and maintaining peer relationships with a wide range of thought leaders. - Excellent written and oral communication skills including public presentations. - Travel 30%-50%. Education: - MD, PharmD, or PhD in life sciences - Hematology drug development experience desirable Company Description Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and

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demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Additional Information Posted: September 11, 2012 Type: Full-time Experience: Mid-Senior level Functions: Other Industries: Biotechnology Job ID: 3728336 ************************************************************************** Contact Jon Guidi, President at Bullhorn Reach http://www.bullhornreach.com/job/337494_dental-sales-rep-portland-or?utm_campaign=v1&shortlink=976011&utm_content=6&utm_source=linkedin.com&referer=www.linkedin.com&utm_medium=referral World renown company seeks experienced dental sales rep in the SF Bay Area. Great opportunity to make big $$. Dental Sales Rep Portland, OR Salary Plus Commission 150K+ top reps 200+ compensation Full Time Employment I'm interested in your "Job #337494: Dental Sales Rep" job in Portland, OR. Please contact me about the position. -----SEND A RESUME TO BE CONSIDERED---- *********************************************

Jobs That Crossed My Desk Through Sept. 9, 2012 ****************************************************************** Apply on company website Sr. Manager, Sales Training and Development, KI Franchise Onyx Pharmaceuticals - REMOTE (San Francisco Bay Area) Job Description Summary The Senior Manager, Sales Training and Development—KI Franchise will be responsible for working with the Director, Sales Training and Development—KI Franchise to develop and implement a comprehensive “best in class” oncology sales training program that encompasses date-of-hire for new sales associates through ongoing training for experienced sales associates . The plan should include innovative training techniques using the most technically advanced communication tools as well as adult learning concepts. Content should include home study, sales call modeling, computer training, company orientation, product orientation, frequent assessments, speaker program training, advanced selling skills, drug reimbursement training, territory planning training, and advanced institutional medical practice training. Essential/Primary Duties, Functions and Responsibilities:

Implement Sales Training and Development annual plan; strategies, goals, programs and management of expenses in line with Operating Plan

Responsible for the development and execution of innovative and comprehensive sales training programs that will optimize performance-results of the Onyx Sales Team

Effective and synergistic collaboration with Marketing/Product Strategy, Sales Leadership, Medical Affairs and Compliance is required

Update training programs and curriculum as necessary, in order to adapt to changes that occur in the commercial environment and remain “best in class”

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Responsible for the development and execution of innovative and comprehensive workshops as part of Regional and National Sales Team meetings

Effective management, solicitation and collaboration with external partners and vendors.

Ensure that all training initiatives and programs are fully supported and documented with Onyx Compliance Standards

Partner with Senior Sales Leadership to fully leverage Onyx Representative Development System(s)

Attend major oncology and associated medical meetings, such as ASCO, AASLD, DDW, Chemotherapy Foundation, etc, as well as training development meetings like SPBT

Frequent field visits with new and experienced sales professionals to identify training gaps

Other duties as assigned Desired Skills & Experience Requirements Work Experience:

5-10 years oncology experience, including solid tumors Oncology sales experience required Training experience a plus DM experience a plus

Management of Staff: No direct reports upon hire

Location: Field-based position

Functional/Technical Knowledge & Skills: Proactive and strategic thinking with the ability to formulate, develop and execute

comprehensive plans Exceptional oral and written communication skills (via PowerPoint, Word, Excel, and

Outlook) Strong understanding of training technologies Excellent organizational & project management skills; ability to manage multiple

projects simultaneously Excellent problem-solving and management skills Ability to manage projects within budget Ability to manage vendors / contractors Exceptional negotiation, facilitation, presentation, and decision-making skills Ability to communicate with senior management Dynamic, self-starter with strong ability to influence

Customer & Industry Knowledge: Clinical Acumen – the ability to comprehend and effectively communicate complex

clinical data in a meaningful and impactful way. The ability to evolve data into messages

Oncology Business Acumen - demonstrated knowledge and successful experience in navigating the complex oncology business environment. Understanding circumstances and issues that can impede customers/patients access to Onyx products and services.

Ensures innovative Sales Training programs and approaches. Consistently updates all Onyx Training based on commercial needs and environment.

Experience effectively establishing & managing relationships with customers Education/Training:

Bachelors Degree required MBA or other Master’s degree a plus Scientific background preferred

License/Certification Required:

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None required Membership in the Society of Pharmaceutical and Biotech Trainers a plus

Other Requirements: Ability to travel up to 50% of the time, including monthly visits to home office Creative: generates new and unique ideas Resourceful: ability to use limited resources to execute ideas and plans High degree of collaboration and influence management skills

Competencies Business Acumen – recognizes business opportunities and identifies tactical plan to

effectively execute Planning – accurately scopes out length and difficulty of tasks and projects Process management – understanding processes necessary to optimally execute; well-

organized Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted: September 7, 2012 Type: Full-time Experience: Mid-Senior level Functions: Training Industries: Pharmaceuticals Job ID: 3708180 ************************************************************************* Please apply on-line at www.cepheid.com for all positions listed. Buyer Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description As a Buyer, you will manage the large volume placement of non-production and capital purchase requirements while optimizing corporate spend through negotiations on price, transportation, warranty and other related aspects. Complete purchasing activities for development and engineering departments to acquire materials and services in a cost effective and timely manner.

Assist internal customers on general inquiries / deliverables pertaining to placed orders for goods / services, invoice reconciliation and general procurement related issues.

Maintain Purchasing Card and other reconciliation follow up with A/P group. Ensure that RTS materials are processed in a timely manner with documentation

provided to A/P and supplier. Communication with supplier base to ensure that Cepheid Purchasing and Quality

requirements are clearly understood. Acquire and maintain a general technical understanding of products and services

purchased. May perform cost analysis and volume planning for blanket or standing requirements. Obtain materials, components, equipment and services. Assist in the development new supply sources where vendors and suppliers are

inadequate. Support the Cepheid Supplier Diversity Program through the active sourcing, selection

and purchasing activity with Small, Minority, and Woman-Owned Businesses.

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Provide support to other members of the Purchasing group in supporting various procurement and department projects and deliverables.

Requires a Bachelors degree or equivalent with a minimum of 2 years related experience in a diagnostic or pharmaceutical environment.

Experience working with QAD or other inventory management systems. Candidate should be familiar with raw materials used in biomedical device,

pharmaceutical manufacturing. Candidate should also be experienced with SOP's, GMP, JIT, MRP and should have

experience with APICS principles. Candidate should be comfortable and adept at Word and Excel.

Desired Skills & Experience Requires a Bachelors degree or equivalent with a minimum of 2 years related

experience in a diagnostic or pharmaceutical environment. Experience working with QAD or other inventory management systems. Candidate should be familiar with raw materials used in biomedical device,

pharmaceutical manufacturing. Candidate should also be experienced with SOP's, GMP, JIT, MRP and should have

experience with APICS principles. Candidate should be comfortable and adept at Word and Excel.

Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law.

Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: September 6, 2012 Type: Full-time Experience: Mid-Senior level Functions: Administrative Industries: Biotechnology Employer Job ID: 3130 Job ID: 3693887 ____________________________________________________________ Director, Logistics Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description The Director is responsible for leading the Distribution and Warehousing operations. The position has responsibility for implementing and administering all systems and procedures to control inventories and customer orders, as well as insuring the efficient flow of all materials necessary for production and all support functions. Includes initiating improvements in logistics operation and facilitates strategic outlook that will better serve all stakeholders. Additionally, the incumbent is responsible for Transportation and Customs Compliance and Management. This position is responsible for inventory control, domestic and international transportation management, distribution analysis and reporting, as well as, capital project management for

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Warehousing and Distribution. These activities include all personnel recruiting/development and budgeting.

Initial focus on the development of a Traffic function within the organization to support increased global distribution activities.

Administers and directs the implementation of departmental policies & procedures in accordance with Government (DEA, cGMP, FDA,) and Company Policies, Procedures, Goals and Objectives.

Directs the integrity of inventory accuracy for multiple business units handled throughout the supply chain in order to support financial and business strategies and objectives.

Directs the preparation and administration of the operating and expense budgets, freight expense budgets, and group capital project budgets, in accordance purchasing policies of the company.

Develops and implements long terms strategies for Customs, DEA, and Transportation compliance.

Direct the Warehousing and Distribution compliance with all State distribution and warehousing licensing necessary to support customer requirements.

Directs and administers the selection and performance of freight carriers to maximize the service & security to our domestic and international customers.

Directs the development of technical training programs to support Warehousing and Distribution operations and ensures that all employees are trained appropriately to perform their job functions in order to maximize their efficiency and productivity.

Bachelor's degree in Logistics, Supply Chain, Business Administration or Engineering or equivalent experience

Minimum 7 years' experience of logistics, materials management, warehousing and distribution, or supply chain management with at least 5 years people leadership is required.

Demonstrated knowledge and application of FDA, DEA, and DOT standards and regulations. Knowledge and application of cGMP and 21 CFR Parts 210 & 211 is highly preferred.

Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Familiar with the correct handling, storage and disposal of raw materials used in

biomedical device, pharmaceutical manufacturing Ability to operate warehouse equipment including but not limited to forklift and pallet

jack Excellent interpersonal and communication skills, both written and verbal, as well as

high ethical standards Proven business/financial acumen, including demonstrated ability to motivate,

influence, solve complex problems, and drive change at all levels of the organization. Proven ability to work on cross-functional, multi-cultural teams Proven ability to meet deadline in a fast paces changing environment Excellent organizational skills with the ability to coordinate and implement team

projects Desired Skills & Experience

Bachelor’s degree in Logistics, Supply Chain, Business Administration or Engineering or equivalent experience

Minimum 7 years’ experience of logistics, materials management, warehousing and distribution, or supply chain management with at least 5 years people leadership is required.

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Demonstrated knowledge and application of FDA, DEA, and DOT standards and regulations. Knowledge and application of cGMP and 21 CFR Parts 210 & 211 is highly preferred.

Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Familiar with the correct handling, storage and disposal of raw materials used in

biomedical device, pharmaceutical manufacturing Ability to operate warehouse equipment including but not limited to forklift and pallet

jack Excellent interpersonal and communication skills, both written and verbal, as well as

high ethical standards Proven business/financial acumen, including demonstrated ability to motivate,

influence, solve complex problems, and drive change at all levels of the organization. Proven ability to work on cross-functional, multi-cultural teams Proven ability to meet deadline in a fast paces changing environment Excellent organizational skills with the ability to coordinate and implement team

projects Preferred Qualifications •CPM/APICS certification •MBA or MS in Logistics, Engineering or Supply Chain •International/domestic traffic experience •5 to 8 years demonstrated experience in a logistics leadership capacity of multiple facilities in pharmaceutical or biotechnology industry Physical Demands •Ability to lift up to 50 pounds Please apply on-line at www.cepheid.com. Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law. Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: September 4, 2012 Type: Full-time Experience: Director Functions: Product Management Industries: Biotechnology Employer Job ID: 3121 Job ID: 3684289 _________________________________________________________________ Inventory Control Manager Cepheid - US - Sunnyvale, CA (San Francisco Bay Area)

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Job Description Responsibilities include activities related to the receiving, storing, managing of materials and finished goods.

Ensures materials are received from proper vendors, that they are delivered to inventory, and that finished goods are packaged according to specification and shipped in a timely manner

Ensures the security and accountability of materials and goods using established inventory control procedures

Ensures materials are available to meet production schedules and/or products are shipped as per marketing schedules

Establishes and modifies operational methods and procedures for inventory management, cycle counting and physical inventories

Maintains documentation to support compliance, effectiveness and efficiency of department activities

Responsible for ensuring that the warehouse is operating under strict GMP guidelines Uses appropriate GMP/ISO requirements, processes and operational policies in selecting

methods and techniques for obtaining solutions Selects, develops and evaluates personnel to ensure the efficient operation of the

function Provides guidance to subordinates within the latitude of established company policies Acts as advisor to subordinates to meet schedules and/or resolve technical problems Anticipates, communicates and resolves internal and external issues that could affect

warehouse optimization Continuously achieves good customer service while following guidelines to support best

business practices Works on issues of diverse scope where analysis of situation or data requires evaluation

of a variety of factors, including an understanding of current business trends May have budget responsibilities Bachelors degree or equivalent experience 5 to 8 years experience in a supervisory or management capacity Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Strong working knowledge of GMP's and Code of Federal Regulations related to

inventory control Familiar with the correct handling, storage and disposal of raw materials used in

biomedical device, pharmaceutical manufacturing Ability to operate warehouse equipment including but not limited to forklift and pallet

jack Excellent interpersonal and communication skills, both written and verbal, as well as

high ethical standards Capability to manage multiple priorities, organize complex requests, and resolve issues

creatively Excellent organizational skills with the ability to coordinate and implement team

projects Desired Skills & Experience

Bachelors degree or equivalent experience 5 to 8 years experience in a supervisory or management capacity Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Strong working knowledge of GMP’s and Code of Federal Regulations related to

inventory control

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Familiar with the correct handling, storage and disposal of raw materials used in biomedical device, pharmaceutical manufacturing

Ability to operate warehouse equipment including but not limited to forklift and pallet jack

Excellent interpersonal and communication skills, both written and verbal, as well as high ethical standards

Capability to manage multiple priorities, organize complex requests, and resolve issues creatively

Excellent organizational skills with the ability to coordinate and implement team projects

Preferred Qualifications • CPM/APICS certification is preferred • International/domestic traffic experience preferred Physical Demands Ability to lift up to 50 pounds Please apply on-line at www.cepheid.com. Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law. Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: August 30, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Biotechnology Employer Job ID: 3117 Job ID: 3661647 ______________________________________________ Product Transfer Scientist Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description The Product Transfer Scientist will combine knowledge of basic molecular biology, real-time PCR, fluidics, and a technical understanding of Cepheid systems to play a key role in product sustaining and support within the Product Transfer group. Lead the Manufacturing, Quality and Planning Departments in assuring the continued production of cost-effective quality products. Identify and implement streamlined and improved processes. Occasionally lead activities of junior staff.

Successfully implement assay/process/product improvements in Production, including: o Project planning and timeline management o Risk assessments o Costing

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o Training of personnel, as required o Implementation of all supporting documentation (BOMs, SOPs, worksheets, etc.) o Updating design history and other documentation

Design and execute validation/qualification activities on reagents, parts or processes. Coordination of multidisciplinary teams is often required. Act as the technical lead representing Operations in project team meetings. Provide coordination of Operation activities as needed to support projects. Provide technical support to the Manufacturing, Quality and Materials/Planning

Departments which may involve assessment of reagent formulations, process or test method development and/or troubleshooting existing product performance issues within the organization.

Lead investigations within production; design laboratory experiments and execute hands-on when needed, to assist in troubleshooting, process development or improvement activities.

Master's degree in Life Science or a related discipline with 6+ years of relevant professional experience. Or, Ph.D. in Life Science or a related discipline with 4+ years of relevant professional experience.

Track record of successful project leadership and cross-functional project management in a regulated industry

Experience working in a regulated industry such as biotechnology, medical device, etc. Excellent organizational and communication skills (oral and written) Ability to work independently and provide effective updates at executive level Ability to successfully lead multiple projects simultaneously towards completion within

short deadlines Desired Skills & Experience

Master's degree in Life Science or a related discipline with 6+ years of relevant professional experience. Or, Ph.D. in Life Science or a related discipline with 4+ years of relevant professional experience.

Track record of successful project leadership and cross-functional project management in a regulated industry

Experience working in a regulated industry such as biotechnology, medical device, etc. Excellent organizational and communication skills (oral and written) Ability to work independently and provide effective updates at executive level Ability to successfully lead multiple projects simultaneously towards completion within

short deadlines Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law. Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: August 27, 2012

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Type: Full-time Experience: Mid-Senior level Functions: Science Industries: Broadcast Media Employer Job ID: 3023 Job ID: 3640228 *********************************************************************** Posted by Nancy Symonds, President, NJS Recruiting Services SR. CRAs - HOME BASED POSITION - ONCOLOGY We are seeking 2 experienced CRAs for a CRO that specializes in oncology trials. The person can be based in any Western State but the Bay Area is a preference as the hiring manager is based here. Must be able to travel 50% and oncology experience is required. Thank you for forwarding this info to clinical professionals you know. ************************************************************************* Posted by Connie Andrews, Vice President, Global Services at Pharm-Olam International & UC Berkeley extension Biosciences Instructor Full time and contract CRA positions with Pharm-Olam International. Send resume to: desiree.futrell@pharm-olam.com ********************************************************************** Frauke Schorr, Ph.D., Team and Leadership Development | Communication | Performance & Productivity, Centered Leadership Institute Seeking Independent Sales Contractor for Ambitious Boutique Corporate Consulting/Training Company This opening is a great opportunity for a business development representative with strong sales drive and self-starter attitude. We are looking to you to find creative and effective ways to expand our client portfolio. Background in sales is a must as well as a genuine interest in the field of corporate learning and development. A background or existing client relationships in the target customer base of Live Sciences or Energy is highly desired. Other customer bases are considered. Centered Leadership Institute is an ambitious boutique corporate training and leadership development company based in San Francisco Bay Area. We are passionate about helping teams and individuals in mid-sized and large companies become more effective at work, build stronger teams, and develop leadership skills. Out differentiator is going beyond simply teaching an understanding of new skills and helping clients to integrate new skills successfully into daily routines for increased productivity and efficiency. We "walk the talk": Not only are we passionate about making a difference to corporations but we also believe in what we teach and we live it. We are looking for someone who aligns with our philosophies. We are looking for a commission-only independent contractor. We have a differentiated product and are looking for the right person to bring this to a wider marketplace. The ideal candidate will have • A friendly, easy, and open attitude towards clients and team members • A corporate demeanor with an empathetic and polite angle • Able to effectively communicate in English, in both written and oral forms • Be persistent in finding new clients and nurturing existing relationships without giving the

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client the feeling of being 'sold to' • Understands that listening to clients' needs is an important skill for a good sale • Creative and passionate in promoting Centered Leadership Institute's services • Have a strong interest in learning and growing. Do you consider yourself a life-long learner? • Highly organized in keeping track of projects and clients Duties: • Identifies development potential in accounts by studying their current business; interviewing key customer personnel and company personnel who have worked with customer; identifying and evaluating additional needs; analyzing opportunities. • Initiates sales process by building relationships; qualifying potential; scheduling appointments. • Develops sales by making initial presentation; explaining service enhancements and additions; introducing new services. • Develops new training by preparing specifications; conferring with principles. • Closes sales by overcoming objections; preparing contracts. • Contributes information to sales strategies by evaluating current results; identifying needs to be filled; monitoring competition; analyzing and relaying customer reactions. • Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. • Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. • Maintain and updating sales funnel in Salesforce.com Compensation: Commission-based compensation only. Please do not contact job poster about other services, products or commercial interests. ************************************************************************* Eric Andrew Morse, Scientific Recruiter at R&D Partners http://bull.hn/l/REWP/1 Immediate hire for a Research Associate in South San Francisco, CA! Research Associate, Molecular Biology in South San Francisco, CA As a Research Associate, your duties will be to provide support for our Research, Development, and Clinical Laboratory. You will be working cooperatively in a busy laboratory environment, responding to change with flexibility and adapting quickly to evolving circumstances. This is an excellent opportunity for a team player to participate in the growth of a fast-paced, pioneering company that is developing systematic approaches to applying molecular diagnostics to health, disease, and medical practice. Responsibilities include: • Unpack, check and verify specimens received against accompanying requisition forms. • Follow established protocols for specimen processing, testing, and data recording. • Properly categorize and file samples into their proper storage locations. • Label, validate, accession samples and enter patient information into the Laboratory Information Management Systems (LIMS). • Provide assay support using ELISAs and multiplex technology for the Development Labs activities including: study sample analysis, assay troubleshooting, automation support, assay development, assay characterization and assay verification.

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• Perform scheduled maintenance on laboratory instruments and equipment. Qualifications: • B.S. degree in molecular biology, genetics, biochemistry or equivalent experience preferred. • Familiarity with standard molecular biology techniques strongly preferred (i.e. ELISA, RNA and DNA Preparations) • Comfortable working in a laboratory environment and able to handle specimens. • Experience with basic laboratory skills (pipetting, sample handling, etc.) required. • Experience with using Laboratory Information Management Systems (LIMS) desirable. • Ability to quickly adapt and apply new methods and technologies. • Proficiency in using basic word processing and spreadsheet applications. • Must have strong interpersonal and organization skills. • Ability to communicate clearly and effectively in writing and verbally. • Able to prioritize and drive to results with a high emphasis on quality. ******************************************************************* Posted by Leslie Miller, Experienced Operations & Administration Executive Innovation & Discovery in Biopharmaceuticals, Translational Medicine…PRINCIPAL SCIENTISTS & DRUG DISCOVERY positions at Celgene http://bit.ly/celgeneresearch …CELGENE is a global biopharmaceutical leader committed to improving patient lives and named #12 on Forbes Top 100 Most Innovative Companies. Ready to join the team and contribute to Celgene’s scientific and commercial achievements? http://www.beaker.com/Celgene_Research Research Scientist Jobs jobs.celgene.com Careers Home | Research Scientist Jobs Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. What is it that defines Celgene? Most fundamentally, Celgene is its employees, who are... -------------------------------------------------------------------------------------- Innovation & Discovery in Biopharmaceuticals…SENIOR CLINICAL SCIENTISTS & CRA positions at Celgene http://bit.ly/celgeneclinical …CELGENE is a global biopharmaceutical leader committed to improving patient lives and named #12 on Forbes Top 100 Most Innovative Companies. Ready to join the team and contribute to Celgene’s scientific and commercial achievements? http://www.beaker.com/Celgene_Clinical Clinical Jobs jobs.celgene.com Careers Home | Clinical Jobs Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. What is it that defines Celgene? Most fundamentally, Celgene is its employees, who are focused... ***************************************************** Senior QA Document Control Specialist – Full Time (San Francisco Bay Area) PPBI To view this position and other current positions please visit www.JGBBioPharma.com. Interested parties should contact LSantiago@JGBBioPharma.com. No Work Visa sponsorship is available for this job. DESCRIPTION: Creates and implements all aspects of the Company’s Document Management programs and is responsible for other computer system designing and management responsibilities with respect to conformance to the regulatory and quality requirements for the manufacture of pharmaceutical and medical devices as required for Food and Drug administration (FDA) and international regulatory agency approval. Supports Pre-approval Inspection (PAI) Audits, and

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New Drug Application (NDA) submission Essential Duties & Responsibilities • Creates, maintains and administers Document and Change Control procedures • Creates, maintains and administers Document Control and Change Control logs and databases • Contributes as a lead to work plans for selection, validation and implementation of EDMS • Administers enterprise systems for document and change control • Implements file naming conventions and standards for consistent file names and file structure hierarchies. • Performs duties in support of established records management procedures, including scanning and logging records and storing records in offsite storage. • Provides support for PAI/NDA submission activities. • Establishes standards for document formatting. • Prepares document requests during regulatory inspections. • Provides document control assistance and support to the user community as required. • Reviews change control packages for correctness and completeness. • Tracks and trends outstanding Change Control and Document Control Requests. • Interacts with business partners by providing technical solutions to Document Control issues. • Conducts Document Control training. • Resolves complex Document Control issues • Prepares key performance indicator metrics EXPERIENCE AND QUALIFICATIONS: • Typically requires a minimum of eight years of related experience and/or combination of experience and education/training. • Medical device industry experience. • Very organized, prioritizes well, can handle deadlines under pressure • Works well with others and cross-functionally • Has experience with Windows 7, Office and SharePoint 2010, implementing and administering MasterControl or similar EDMS, Microsoft Access database designing. • Experience creating training materials, training groups and individuals and providing metrics on training. • Performs a diverse scope of complicated tasks. • Has wide-ranging experience in area of specialization. • Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways. • Frequently applies technical standards, principles, theories, concepts and techniques. • Applies strong analytical and business communication skills. Organizes and prioritizes numerous tasks and completes them under time constraints. • Demonstrated success in problem solving. • Ability to recognize deviation from accepted practice and to exercise judgment in resolving routine problems. • Applies strong analytical and business communication skills. • Experienced professional with a full understanding of area of specialization. • BS/BA degree in related discipline and four years of related experience; or, • MS/MA degree in related discipline and two years of related experience. To apply for a position send your resume to LSantiago@JGBBioPharma.com Posted by Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com *************************************************** CONTACT & additional info: *** SEE www.fpccareers.com FOR FULL POSTING of this and other opportunities ***. Also, contact Ira Mann at ira@fpccareers.com

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Validation Manager - CSV - Biopharmaceutical (permanent) - California Global Biologics leader undergoing an expansion of over 1 billion seeks a Senior Manager to lead Computer Systems Validation, Delta V and areas including the below: Top Challenges: 1) Manage staff and provide direction in multiple computer system validation projects and drive to project completion in accordance with established timelines. Priority projects and relevant equipment include : a) New lyophilization equipment with related PLC/Allen Bradley and SCADA systems b) UF/DF & chromatography skids c) Centrifuges and filter presses d) Delta V e) Electronic Batch Records 2) Review current program against current industry standards and identify gaps. Fix gaps as needed 3) As manager of the computer systems validation, the incumbent will focus on best practices and set local policy and procedures. Incumbent will be responsible for project plans and coordination of computer system validation approaches. Develop and implement new validation approaches as needed. 4) Lead the development and execution of computer systems validation project strategies crossing Engineering, Technical Services, Manufacturing, QA/QC and Regulatory disciplines. Responsible for defining scope of work for project teams. 5) Manage, identify, hire, and develop team to support validation activities. Manage continued growth, development, and retention of the team. Location: California CONTACT & additional info: *** SEE www.fpccareers.com FOR FULL POSTING of this and other opportunities ***. Also, contact Ira Mann at ira@fpccareers.com Qualifications (which should be clear on resume) : 1) 7+ years of validation experience with specific demonstrable experience in CSV 2) Delta V expertise 3) Strength in PLC, SCADA and EBR (electronic batch record).

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4) 4+ years of supervisory experience including multiple cross-functional teams simultaneously. 5) BS Degree in Engineering or Computer Science 6) Experienced in project management, resource management and budgeting. 7) Experience specific to biologics, biotechnology or biopharmaceutical industry (preferred). Key Words: CSV, computer systems validation, Delta V, EBR, electronic batch reporting, SCADA, PLC, project management, budgeting Search Jobs: Results: Validation Manager - CSV - Biopharmaceutical... fpcnational.com Global Biologics leader undergoing a large multi site expansion seeks a Senior Manager to lead Computer Systems Validation, Delta V and areas including the below: 1)Manage staff and provide direction in multiple computer system... ****************************************************** Posted by Alexander Cohen 858.427.0680, Recruiter at Simply Biotech http://bull.hn/l/REN3/5 Looking for a Quality Engineer in the Carlsbad, CA area for a Medical Device company. ISO 13485 experience required. Know anyone for this job? QUALITY ASSURANCE ENGINEER in Carlsbad, CA QUALITY ASSURANCE ENGINEER Simply Biotech specializes in recruiting exclusively for the biotech community. We are currently seeking a Quality Assurance Engineer for a leading and growing North County device firm. The qualified QA Engineer is responsible for serving as a technical resource of the Quality/Regulatory group. This position supports complaint and RMA investigations and documents all decisions appropriately. This position is also responsible for initiating the development, implementation and maintenance of policies and procedures to ensure compliance with Quality System Regulations (QSR 820) and ISO 13485, for medical devices and for performing other Quality System activities as needed to ensure quality and regulatory compliance. The Quality Assurance Engineer will also handle the following: * Continuous improvement activities to enhance the quality system, such as Lean manufacturing, Six Sigma, Cost of Quality, 5S, Kaizen, etc. * Perform Test Method Validations, Gage R&Rs, SPC. * Maintain quality metrics and trend charts. * Write Technical Documents such as Validation Protocols, Test Procedures, and Test Reports in a concise and clear manner using statistical techniques. This also includes reviewing and approving test results/product release documentation. * Support manufacturing if/when there are quality issues by performing failure analysis, and Collaborate on product and process validations. * Analyze rejects in relation to design specifications and test objectives to determine source of problem and eventually make recommendations to modify or adjust process/design to meet specifications.

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* Analyze reports of technical problems to determine trends affecting future design, production, service and maintenance processes and eventually recommend modifications to eliminate future problems. * Coordinate problem resolution with manufacturing, engineering, customer service and other departments. * Support Quality and Control Plans * Provide technical support to the R&D, Engineering (molding and manufacturing), Materials, Purchasing, and Manufacturing departments during the design phase, transfer, and production. * Support complaint and RMA investigations to determine the root cause of the problem. Work with manufacturing, R&D, and Engineering to develop an appropriate solution to any issues found. * Perform or assist in performing supplier audits, evaluations, and assessments as required. * Support the Quality Control Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system. * Understanding of the Food and Drug Administration (FDA) and ISO 13485. The Quality Assurance Engineer will possess the following qualifications: * Bachelor?s degree (BA/BS) from four-year College or university * 4+ years of related experience and/or training; or equivalent combination of education and experience. * ASQ Certified Quality Engineer (CQE) preferred. * ASQ Certified Six Sig... ******************************************************************** Biotech Manufacturing Engineer CMC Biologics A/S - San Francisco Bay Area Job Description Responsibilities:

Execution of batch operations as described in Standard Operating Procedures (SOPs) and batch execution records including, but not limited to: Cleaning, Expansion, Cell Culture, Harvest, Filtration, Purification, Formulation and Final Fill activities

Review / approval of completed batch execution records and related cGMP documentation • Assist in scheduling of Technical Operations staff to support operations activities

Perform Root Cause Analysis (RCA) in support of investigation and documentation required in a cGMP environment

Assist in project management for process and utility improvement projects Providing analytical, data management, and equipment support Troubleshooting and analysis of equipment malfunctions to assist in repair and return to

service activities Specification of equipment and process parameters Facilitation and/or execution of equipment on-boarding/commissioning activities Technical direction and training of equipment operations to colleagues Promoting a safe working environment Attainment Indicators: Standardization of processes Right First Time batch execution Development / Training of colleagues Restore Lost Function • Safe working environment Perform his/her tasks diligently and in compliance with requirements in CMC’s Quality

System Other duties as assigned

Desired Skills & Experience Requirements:

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BS in Engineering or related field / equivalent experience. 8+ years engineering experience in Biotechnology Manufacturing operations,

Maintenance, Design, Process Improvement, Root Cause Analysis (RCA) Knowledgeable in the following systems: BioRx operations, Chromotography System

operations, Biopharmaceutical Filtration operations, Instrument and Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM); Pharmaceutical Utilities

Proven expertise in planning/organization/execution of operation and maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams.

Ability to work hours necessary to support production and /or maintenance activities. Ability to lift up to 40 lbs. with assistance. Ability to work in confined spaces and near operating equipment. Ability to work in loud noise environments.

CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE For immediate consideration please email your CV to dwoolsey@cmcbio.com highlighting the position in the subject line or apply directly at http://tbe.taleo.net/NA5/ats/careers/requisition.jsp?org=CMCICOS&cws=1&rid=426. Company Description CMC Biologics A/S is a contract manufacturing organization, with manufacturing facilities in Europe and the USA. The company offers a wide range of integrated cGMP manufacturing services using microbial fermentation and mammalian cell culture processes. CMC’s Copenhagen Manufacturing Facility is the first CMO in Europe who has a 2000 Liter Single-use Bioreactor . CMC's headquarters are located in Copenhagen, Denmark, part of Medicon Valley region. Its US facilities, are located in Seattle, WA and Berkeley, CA. Our Mission is to realize the potential of our customers’ biopharmaceuticals by contract process development and manufacture. Our Vision is to be a world market leader in biopharmaceutical contract services in term of quality, know-how and timeliness. Additional Information Posted: September 5, 2012 Type: Full-time Experience: Mid-Senior level Functions: Manufacturing Industries: Biotechnology Job ID: 3692573 *********************************************************************

Qualified candidates please reply to: Cindy Johnson cjohnson@chozeninc.com tel: 925-577-8135

Most Urgent Positions:

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R&D Project Coordinator Staff Systems Engineer R&D Project Engineer Product Director (Marketing) R&D, MANUFACTURING & OPERATIONS ROLES

R&D Project Coordinator

6+ years experience as a Project Coordinator (R&D support preferred) in a medical device company

Must possess strong communication skills, both written and verbal Strong attention to detail Exceptional organization skills are a must. The ability to multi-task and prioritize within multiple projects is essential. This position requires expert proficiency in Word, PowerPoint and Excel, working

knowledge of Design History File, ECO and Design Control processes.

R&D Project Engineer

BSME required, MSME preferred 3+ years experience in R&D within medical device industry Startup or small company/team experience strongly preferred Proven experience taking a project from concept to commercialization SolidWorks, catheter / implantable device experience required

Staff Systems Engineer

BSEE, advanced degree preferred A minimum of 7 years experience in embedded systems hardware development A minimum of 5 years working in the FDA compliant medical system Strong background and working knowledge of Electronics Design on embedded system

for medical applications. Mechanical knowledge for the system development a plus. Working knowledge of international standards for medical systems, including the

IEC60601 series Experience in medical device development from concept to commercialization

_______________________________________________________________________

REGULATORY, QUALITY & CLINICAL AFFAIRS

Clinical Applications Specialist ( field based)

Bachelor’s degree 10 years experience as a Clinical Applications Specialist in medical device industry Ophthalmic knowledge/experience is a strong plus Extensive travel required – 60% - 80% (must live near international airport)

Director of QA, RA (timing will be late Q4)

BSEE or BSME, advanced degree preferred

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10+ years experience in leading the QA & RA functions within the medical device industry

Medical capital equipment experience required Experience working with CMO’s strongly preferred Startup experience required

_______________________________________________________________________

SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT

Product Director, Software Products

BA, BS degree required, MBA preferred Minimum 5 years experience in marketing within medical software and capital

equipment Experience marketing medical software products is required Proven business development & product management skills are required Experience working directly with physicians and healthcare professionals on new

product and application development

Sr. Product Manager (based in Vancouver, WA)

Bachelor’s degree in business or medical field with 7-10 years Product Marketing experience. M.B.A. and/or sales experience is a plus.

Medical market experience required, ideally in pain management, orthopedic, or neuro applications and confidence in interacting with physicians, and medical technologies such as ultrasound and radio frequency.

Proven track record of adaptability and ability to extend existing and develop new relationships and marketing initiatives to make them valuable and effective in our market segment.

*********************************************************** Job Summary Date Posted: 8/9/12 Location: San Francisco, Ca, CA Job Contact Phone: 415.432.6665 Senior Corporate Counsel Medivation Job Description

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Corporate Counsel.

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Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers.

The Senior Corporate Counsel is a new position for Medivation and will be an opportunity for the right individual who has the drive, and the desire to be on the ground floor and play a key role in the commercialization of new medicines, consistent with US healthcare laws and regulations.

Essential job functions include but are not limited to the following:

Responsible for providing advertising and promotion, contracting, regulatory and general legal support to the commercial and medical affairs organization. Includes daily interaction with the U.S. based brand team(s), Marketing departments, Medical Affairs and Regulatory Affairs departments, and interaction with Headquarters and other affiliates as required. May interact with government agencies, law firms, trade organizations and other external agencies.

Serves as lead counsel for one or more pharmaceutical brand(s), and includes participation in multidisciplinary committee in review of advertising, scientific and other materials

Draft, review and negotiate product-related commercial contracts, 3rd party vendor agreements, service agreements, consulting agreements and other corporate agreements

Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align and achieve business strategic goals

Serve as a business partner in support of key customer group(s) with oversight and guidance by the General Counsel

Keep informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed

Requirements:

Expertise in FDA advertising and promotion regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code

J.D. with 8-15 years relevant industry and/or law firm experience A State Bar admission required Experience at a pharmaceutical or biotech company supporting marketed products Strong problem-solving and decision making skills with demonstrated ability to think

creatively and devise solutions to challenging problems Occasional travel required

******************************************************************* Beth Mackenzie Office Manager Global Recruiters of West Palm Beach (561) 422-5150 Phone (440) 425-5150 Fax emackenzie@grnwestpalmbeach.com www.grnwestpalmbeach.com Marketing Research Manager # 1171

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A global leader in diabetes diagnostics, offering a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics is seeking a Marketing Research Manager to develop actionable business insights, implications, and strategic recommendations from analysis of primary marketing research and other secondary and syndicated market research information Key Duties, Activities and Responsibilities:

Create and manage internal systems for the timely and accurate collection, analysis and dissemination of information and insight derived from primary research.

Partner with internal groups to measure the market impact of marketing programs. Provide tools to marketing channels to forecast profitability of programs and to measure

actual profitability after the programs have executed. Develop recommendations based on these analyses for future marketing efforts.

Provide inputs to annual planning process and manage monthly reporting processes on market conditions, competitive performance, and explanation of drivers of observed market conditions.

Develop and manage relationships with key vendors and suppliers. Build and develop high performing Marketing research team. Develop annual budget for Marketing Research and track performance against that

budget monthly. Negotiate for necessary funding and cross-functional resource needs. Research and recommend additional syndicated market research purchases to drive

increased understanding of the business and opportunities to drive competitive differentiation and business growth.

Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.

Serve as marketing research expert related to customer needs, market conditions, competitive activity.

Accountable for providing actionable business insights implications, and strategic recommendations from analysis of primary, secondary and syndicated market research information.

Work Experience, Skills and Education Required:

8 years (or 6 years with MBA) combined sales, marketing or marketing research. Previous healthcare experience preferred. Exceptional analytical, mathematical and problem solving skills Excellent oral and written communication skills (including presentation and listening

skills) High energy level and positive attitude; confidence Integrity and professionalism Initiative and self-motivation; strong work ethic Career ambition Organizational skills and attention to detail Leadership and team orientation; ability to work with others; ability to work in a

matrixed environment Bachelor's degree required; MBA preferred

________________________________________________________________ Director of Marketing - Automation, CA # 1114 A major global pharmaceutical, biotech and diagnostics company is searching for a Sr. Product Marketing Manager Core Products. The incumbent will assist with development of comprehensive marketing plans for new and on-market products in the company’s Core Products portfolio.

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Key Duties, Activities and Responsibilities: · Assess customer needs, competitive risks, and long-term market potential. · Outline successful marketing strategies that include activities to support full portfolio of

instrumentation, assays and reference lab services. · Identify and resolve specific business issues and opportunities that arise. · Market expertise in the Core Products market, understand what factors influence and shape

the market including: growth trends, industry and competitive analysis, environmental conditions, technologies, and capabilities.

· Sales support – Effectively translate market strategy into support for sales objectives. · Customer focus – Identify opportunities and threats in the marketplace by attending trade

shows and symposiums, and interfacing with customers and KOLs. Work Experience, Skills and Education Required: · Bachelors of Science and/or Masters in Business Administration · 6+ years experience in diagnostics marketing or sales. · Blood banking or infections disease testing/instrumentation experience highly desirable · Laboratory experience preferred · Technical background in Core Products strongly preferred · Data analysis and writing market development plans a plus · Ability to manage agencies, suppliers and budgets. · Ability to manage project teams and projects within deadlines · Ability to take direction well and follow-through on projects · Ability to work on multiple projects simultaneously · Strong written and oral communication skills. · Ability to work well within a team as well as independently. Strong strategic skills. ____________________________________________________ Marketing Manager, CA # 1110 A major global pharmaceutical, biotech and diagnostics company is searching for a Marketing Manager. Responsible for Product Marketing and certain Diagnostics regional external customer and internal communication, including market communications, product launches, communication plans, and congresses/events. Key Duties, Activities and Responsibilities: · Assist with development of key customer business plans and of Marketing Plan for Blood

Screening and Blood Typing products. · Develop current and relevant sales tools and training of sales force · Monitor competitive tactics and strategies, conduct regular competitive reviews and

communicate throughout AMERICAS Team · Assist in analysis of market trends through customer contact, attendance at scientific and

appropriate blood bank meetings · Work with the Americas Commercial team to execute all logistics associated with marketing

events, scientific, media, advisory board meetings, congresses and customer meetings throughout the Americas

· Region while adhering to all SOPs regarding compliance and timeliness of review · Develop and implement product lifecycle for the Americas region – regulatory, scientific,

customer service, quality, supply chain. · Develop monthly forecast; conduct analysis and monitor business results against budget and

plan; develop proposals for new products and product improvements · Work with regional marketing managers and global marketing and communications team to

develop, coordinate, and execute country-specific communication plans · Liaise with Global Marketing and Communications functions to ensure consistent message in

all forums (print, congress, interviews)

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· Ensure consistency of Novartis brand and market position in external communications, by ensuring alignment at all levels.

· Participate in the development or modification of marketing collateral to be used in the AMERICAS market to promote the sale of Diagnostic Division products

· Implement Sponsorship and Marketing expenses, track and process all associated budgets and expenditures..

Work Experience, Skills and Education Required: · BS in life science or marketing and/or MBA highly preferred Emphasis in liberal studies,

English, communications, public relations, or journalism preferred · 5 years marketing experience with 3-6 years experience in sales and marketing organization

in diagnostics/medical devices, with emphasis on product development and project management required

· Experience in communications positions, including high-level involvement in marketing communications, media and Key Opinion Leader relations

· Strong written, verbal, and interpersonal communication skills. · Excellent attention to details and detailed planning. · Ability to work independently, as well as in close collaboration is required. · English is mandatory; other languages including but not limited to Spanish, Portuguese,

French preferred ______________________________________________ Hospital Service Representative NW Region (CA) # 1190 A leading global healthcare technology company that manufactures and distributes diagnostics / medical devices products and services is looking for a Hospital Service Representative to hire, lead, coach, train and develop the Hospital Service Team and assist Hospital Account Managers as they service customers as well. Responsible to develop retention strategies for assigned area which ensure profitable growth aligned with all company business objectives, and high levels of customer satisfaction. This will include Hospital Service Rep lead generation accountability, supporting marketing and sales initiatives and collaboration between service and sales. Key Duties, Activities and Responsibilities: •Develop service plans for retention and expanding existing accounts. Ensure the implementation of national and regional service plans and strategies. Ensure team meets retention targets by growing profitable base business and generating client loyalty. •Partner with the Hospital Sales Director and the Business Unit and operations to develop overall business unit plans for increasing profitability of the existing business through targeted plans and execution of national strategies and initiatives. •Lead the service team in developing account-specific strategies to profitably grow and maintain the business. Provides guidance to team members to ensure successful implementation of service plans and developing approaches to minimizing/handling obstacles. •Implement account management, pricing and marketing initiatives. Manage all service processes such as pricing and service changes to ensure customer's needs and business objectives are satisfied. •Ensure service team adheres to all Compliance programs and government regulations. •Ensure that budget expectations are met, including applicable lead generation and retention forecasts. •Responsible for working within all company testing sites, developing relationships internally with the operations team, attending service meetings, market strategy meetings (as required) and communicating strategies. •Facilitating conference calls or meetings with key operations staff to address service problems with the service team identifying service trends and potential resolutions. Communicate those solutions back to customer for resolution.

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•Serve as consultant to Hospital Sales Director on key strategy and service management issues. •Manage all administrative and reporting tasks for position including managing special projects or initiatives as assigned by the Hospital Sales Director. •Responsible for the recruitment, selection, retention, and motivation of the service team including training, development, and performance management. Qualifications Work Experience, Skills and Education Required: •Bachelor's degree in a Business, Marketing or the Life Sciences •At least five years of successful direct outside sales and service in a healthcare field. •Prefer at least three years of supervisory experience within the healthcare industry with proven ability to direct and influence others to achieve common goals •Demonstrated ability to operate successfully in a complex organization structure •Ability to develop and sustain strong customer relationships. •In-depth knowledge of sales management, market strategy and the healthcare industry •Excellent quantitative analysis skills •Excellent Microsoft Office and other computer skills •Must have strong collaborative Communication skills •Solid verbal and written presentation skills •Strong planning and organizational skills •Per week, at least 3 consecutive days of travel working in the field is required, requiring overnight stays. ____________________________________________________________ Market Development Manager # 1200 A molecular diagnostics company committed to providing safe, highly accurate and affordable prenatal tests for maternal and fetal health is seeking a Market Development Manager to be responsible for developing and executing sales strategies for large business development opportunities such as Integrated Delivery Network (IDN) and Independent Practice Association (IPA) clients that include hospital affiliates, medical clinics and group practices. This sales professional will be responsible for securing contracts with IDN and IPA clients and for these clients, meeting or exceeding established program sales goals and market share targets within a given geographical territory; and will introduce a new clinical technology to providers, individual hospitals, and maternal care centers in the women’s health community, with a critical focus on increasing prenatal test adoption in the defined market. Key Duties, Activities and Responsibilities: · Working with the commercial management team to identify IDN and IPA client opportunities · Develop and implement territory sales strategies, detailing, competitive differentiation,

presentation, closing, implementation and post-adoption follow up. · Utilize effective sales techniques in order to gain access to decision makers and influence

purchasing decisions. · Apply strong interpersonal skills to establish relationships of trust that allow for directed

probing to uncover the IDN and IPA client needs and develop solutions within the company framework that meet these needs.

· Build IDN/IPA alliances, establish and maintain product market leadership, and achieve long and short-term sales objectives by providing solutions and creating relationships between the Company and IDN/IPA clients.

· Engage co-marketing partners of the Company and create productive relationships with sales executives of those partners.

· Consistently meet established territory sales goals by targeted call points. · Utilize CRM database to document territory management activities, including pre-call planning

and call reports, as well as to document competitive intelligence.

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· Prepare territory plans as required. · Interact with all levels of the health systems and care delivery organizations or other

assigned targets/clients on a regular basis. · Participate in, and travel to, tradeshows and other medical education/outreach events, as

needed. Work Experience, Skills and Education Required: · We seek a proven individual with a successful track record in complex health care sales

environments, preferably with a background in both healthcare systems selling and provider selling.

· Previous experience: 5+ years of progressively responsible sales experience with IDN and IPA clients

· Experience with prenatal diagnostics and/or capital equipment in a hospital system setting strongly preferred

· Education: Bachelor’s Degree or higher · A team player and superior interpersonal skills · A strong track record of sales performance · Ideal candidate will have existing or past history of relationships in the geography with

medical centers, hospitals and health systems and proven ability to successfully navigate and manage a multi-tiered sale

· Must possess a strong scientific and clinical/business acumen · Strong sales skills and presentation skills are required, including written and verbal

presentations · Thinking, planning, and superior organization skills to effectively manage multiple priorities in

a fast paced environment · Basic business skills (budgeting, forecasting, trend analysis) · 50% travel required ___________________________________________________________________ Hospital Account Executive – CA #1123 A leader in diagnostic laboratory testing, information, and services seeks a Hospital Account Executive located in California. To target and secure profitable new business in assigned hospital accounts by building relationships and aligning with regional and national marketing strategies. Key Duties, Activities and Responsibilities: • Target and secure profitable new business in line with regional marketing strategy by

effectively targeting prospective accounts, creating in-depth prospect profiles, building relationships and securing the business.

• Provide overall support and expertise to new accounts to ensure clients receive highest level of quality service utilizing operational personnel to resolve problems and when necessary.

• Participate with local leadership in developing overall business unit plans for increasing volume and profitability through implementation and execution of national strategies and initiatives.

• Prepare and present proposals and bids by using all standard processes, procedures and templates.

• Perform any other tasks as assigned by the manager. • Essential Expectations:

• 80% of New Sales Budget • Proper utilization of Technology Enabled Selling (TES) tool • Proper utilization of Strategic Account Executive

Work Experience, Skills and Education Required: • Bachelor’s degree in Business, Marketing or the Life Sciences;

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• At least five years of successful AND PROVEN front line sales experience including strong “closing” skills

• Ability to develop and sustain strong customer relationships • Strong planning and organizational skills • Excellent oral and written communication and presentation skills • Solid PC skills including working knowledge of Microsoft Software • Knowledge of the healthcare industry • Experience selling products/services into the hospital laboratory is required ___________________________________________________________________________

_____ Hospital Service Manager SW Region (CA) # 1191 A leading global healthcare technology company that manufactures and distributes diagnostics / medical devices products and services is looking for a Hospital Service Manager to hire, lead, coach, train and develop the Hospital Service Team and assist Hospital Account Managers as they service customers as well. Responsible to develop retention strategies for assigned area which ensure profitable growth aligned with all company business objectives, and high levels of customer satisfaction. This will include Hospital Service Rep lead generation accountability, supporting marketing and sales initiatives and collaboration between service and sales. Key Duties, Activities and Responsibilities: •Develop service plans for retention and expanding existing accounts. Ensure the implementation of national and regional service plans and strategies. Ensure team meets retention targets by growing profitable base business and generating client loyalty. •Partner with the Hospital Sales Director and the Business Unit and operations to develop overall business unit plans for increasing profitability of the existing business through targeted plans and execution of national strategies and initiatives. •Lead the service team in developing account-specific strategies to profitably grow and maintain the business. Provides guidance to team members to ensure successful implementation of service plans and developing approaches to minimizing/handling obstacles. •Implement account management, pricing and marketing initiatives. Manage all service processes such as pricing and service changes to ensure customer's needs and business objectives are satisfied. •Ensure service team adheres to all Compliance programs and government regulations. •Ensure that budget expectations are met, including applicable lead generation and retention forecasts. •Responsible for working within all company testing sites, developing relationships internally with the operations team, attending service meetings, market strategy meetings (as required) and communicating strategies. •Facilitating conference calls or meetings with key operations staff to address service problems with the service team identifying service trends and potential resolutions. Communicate those solutions back to customer for resolution. •Serve as consultant to Hospital Sales Director on key strategy and service management issues. •Manage all administrative and reporting tasks for position including managing special projects or initiatives as assigned by the Hospital Sales Director. •Responsible for the recruitment, selection, retention, and motivation of the service team including training, development, and performance management. Qualifications Work Experience, Skills and Education Required: •Bachelor's degree in a Business, Marketing or the Life Sciences •At least five years of successful direct outside sales and service in a healthcare field.

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•Prefer at least three years of supervisory experience within the healthcare industry with proven ability to direct and influence others to achieve common goals •Demonstrated ability to operate successfully in a complex organization structure •Ability to develop and sustain strong customer relationships. •In-depth knowledge of sales management, market strategy and the healthcare industry •Excellent quantitative analysis skills •Excellent Microsoft Office and other computer skills •Must have strong collaborative Communication skills •Solid verbal and written presentation skills •Strong planning and organizational skills •Per week, at least 3 consecutive days of travel working in the field is required, requiring overnight stays. ________________________________________________________________ Senior Director, Business Development– CA # 1037 A leading diagnostics and laboratory services organization that provides products and services in the hematology, oncology and other specialties arenas is seeking a Senior Director, Business Development. Key Duties, Activities and Responsibilities: · The successful candidate will participate in identifying new products for in licensing or

acquisition to offer in our Company clinical lab. · This will include generating preliminary Market models, Technical assessment reports and

financial projections for these opportunities. · The candidate will work closely with Marketing, Finance, Legal, IP, Regulatory and

Compliance in due diligence and generation of contracts and licensing agreements for potential products.

· There will also be close cooperation with our counterparts in cities and interactions with several divisions of Pharma and Business within the Company.

Work Experience, Skills and Education Required: · A strong work ethic and ability to lead multidisciplinary teams · A combination of PhD (preferably in a biological discipline) and MBA is most desired · At least 5 years experience in business development, financial modeling, or quantitative

marketing · A track record demonstrating strong analytic skills in market assessment, valuation, IP

analysis, and technical analysis · Familiarity with use of business and financial databases, and analytic methods · Strong communicative skills with ability to rapidly generate MS Excel and PowerPoint based

presentations and to present them effectively to Sr. Management. · Ability to generate accurate and timely budge · Demonstrated strong personnel management skills · Experience in diagnostics · Knowledge of CPT and disease coding · Familiarity with Laboratory, Marketing and Sales organizations · Familiarity with Pharma organizations ************************************************ ***************************************************** Scott Bailey Senior Partner Ocean Medical, Inc.

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EXPERIENCE. MEANS. OPPORTUNITY. (904) 237-2407 Scott@OceanMedical.Net Skype: scottbailey8 Director Engineering and a Director New Product Introduction for a global, US-based medical device company. This Corporate and US Manufacturing site (Franchise Headquarters), along with overseas manufacturing, has created two new roles:

- Director Engineering (Director Franchise Operations Development Engineering and Process Capability)

- Director NPI (Director New Product Introduction Operations Readiness and Integration) These critical and highly visible roles take into account many aspects of career development, including succession planning, and report into the Worldwide VP Franchise Operations. Working with the highest levels of the Corporation and interaction with the Global Management Board, these Strategic Leaders will cover New Product Introduction Engineering and New Product Introduction Operations capabilities including: Director Engineering: develop new and improve current product process capabilities for overall business growth. This Technical Professional will mentor, lead, and guide the efforts of Fellows, Managers, Senior Managers, and Directors in all stages of new product introduction including process development engineering, design transfer, hi-speed automated equipment capabilities (engineering, installing, validating, debugging, and optimizing), and packaging for final global product launch. Director NPI: entrusted with the stewardship and accountability for the Supply Chain, and all new product introductions and launches within the Franchise. This Development and Operational Professional will mentor, lead, and guide a team of PhD level Analysts, Project Leaders, and Managers that oversee all aspects of cost-efficient technology transfer, global launch, and supply sustainability within the Franchise product portfolio. This will include the integration of all product introduction activities to ensure that all aspects of bringing a new product to commercialization are addressed within the Supply Chain (supplier qualifications, Supply Chain readiness, site selection), and technology transfer through global product launch, from napkin sketch concept to full and long term scale-up production. For both roles, demonstrated professional strengths in communication, leadership, coordination, collaboration, partnering, global thinking, strategic thinking, project management, process orientation, and succession planning are essential. Your current title is likely to be Director R&D, Director Operations, Director Engineering, Director Process Engineering, Director (Equipment) Product Development, Director New Product Introduction and Supply Chain, Senior Director, or VP. Your product experience with hi-speed, automated, capital equipment and associated medical device disposables (perhaps monomer, polymer, silicon, rubber, or packaging) would be considered a valuable asset to the company. ****************************************************** ****************************************************** *************************************************************************

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Other Information for Those in Transition ************************************************************************* *********************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2011 on the biotechnology industry at www.ey.com. This is the 25th anniversary issue using consistent measures to track the industry sector. *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2012 report authored by CHI, PWC and BayBio at http://baybio.org/about/2012-biomedical-report/ ******************************************************* NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 **************************************************** Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace”’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • “enewsletters@fdanews.com ” ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. *************************************************************************

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Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications

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There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you

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have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved.

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*************************************************************************Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://the-scientist.com/2011/12/01/life-sciences-salary-survey-2011/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/issues/2011-06/view_features/2011-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/salary-survey-2010-research-and-development. You can also find salaries for other functions at the same location. 2011 is now available at http://www.mddionline.com/article/salary-survey-2010-research-and-development MM&M reports salaries in the September issue each year. See 2011 results at http://www.mmm-online.com/25th-annual-career-salary-survey/article/211850/ ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers,

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engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************