Marysville, OH 43040

jestertwl@gmail.com

SKILLS & ABILITIES Experienced in method development and validation for the support of ANDA filings and formulation development. Perform trend analysis of data and conduct investigations for OOS and OOT results and well versed in CAPA remediation. Trained in various analytical techniques and actively seeks innovative approaches to improve quality and efficiencies of methodologies to decrease development time. Trained in management of staff with regards to career development, technical competency, performance management and mentorship. Trained in project management and priority setting, analysis of project constraints and mitigation to achieve deadlines. Experienced in regulatory interactions through audit and correspondence with multiple regulatory agencies.

EXPERIENCE ASSOCIATE DIRECTOR, ANALYTICAL DEVELOPMENT, ROXANNE LABORATORIES

July, 2002 - Present

Overseeing method development and method validation for the purpose of 8 to 10 ANDA submissions a year with an emphasis on QbD and QbR. Experienced in the filing activities for IND’s, ANDA’s and NDA’s for solid dosages (IR, MR, & ER), oral dosages (solution and suspension), nasal sprays, multi dose inhalers, sublingual, topical formulations (creams and patches) and injectable products.

Manage three supervisors and staff of 20 analysts with regards to performance appraisals and growing talent, mentorship, career development, interviewing, coaching of staff in method development, method validation, cGMP testing and career aspirations.

Draft and update job profiles for scientists, supervisory positions and business support roles.

cGMP release of product for clinical trials and stability testing with emphasis on trending for the purpose of establishing commercial specifications for drug products. Conduct laboratory investigations for OOS and OOT results pertaining to both development and commercial products.

Interact with the FDA during onsite audits; correspondence in relation to ANDA deficiency letters, CBE0 and CBE30, PAS, Annual Reports, onsite PAI and general cGMP inspections.

Monitor budget as well as developing future budgetary plans for personnel and equipment.

Prepare and review SOP, Work Instruction, Specifications, Procedures and guidance for laboratory use with an emphasis on compliance.

Develop and oversaw designs for new laboratory space with

compliance considerations for both FDA and DEA agencies. Took several projects from design phase, through construction and completed with regulatory inspections for final occupancy and cGMP activities.

Drive the acquisition of new technologies and software to increase the efficiency of development work to reduce timeline to submission. UPLC, Apparatus IV dissolution, ASD apparatus (Artificial Stomach Duodenum) and ASAP (Accelerated Stability Assessment Program) software to model degradation pathways to predict stability trends, packaging optimization and formulation optimization.

Accomplishments:

Trained and experienced in UPLC, HPLC, GC, TLC, DSC, TGA, FTIR, AA, X-ray diffraction, SEM, Dissolution, NIR, and Karl Fischer.

Attended extensive management training conducted by the Fisher College of Business at Ohio State University.

Oversaw construction project of a high contaminate operation for both R&D and quality control laboratories ensuring budget and timelines were adhered. Project included design phase, construction phase, transition of equipment and staff between sites. Completed project with an extensive FDA auditor with a success cGMP approval.

Attended several GPhA conventions, relaying critical information on ICH expectations and developed strategies to address resource deficiencies based upon the new stability requirements. Attend several project manager workshops with FDA at multiple fall conventions.

Presented to the Fisher College of Business Health Case Industry Cluster.

Sponsored, coached, and participated as a team member on several process improvement teams.

Promoted three times within the research and development department.

ASSISTANT LABORATORY MANAGER, RESEARCHJ & DEVELOPMENT, MYLAN PHARMACEUTICALS, INC.

October 1996 – July, 2002

Applying separation techniques to liquids, solid dosages, creams, suspensions, and parenterals for methods development and methods validation for the submission of ANDA’s.

Managing a staff of four employees to support the development of viable generic drug formulations, new drug formulations, and re-formulation of current approved generic drugs.

Qualification, release, and resolving technical issues involved with drug substance, drug product and excipients for cGMP environment.

Creation of CMC sections for IND, NDA and ANDA submissions for FDA.

Management responsibilities include performance appraisals, interviewing candidates, scheduling priorities, and handling day to day morale of the laboratory.

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Accomplishments:

Attended extensive Management training conducted by the College of Business at West Virginia University.

Promoted twice within the research and development department.

Trained in HPLC, GC, TLC and HPTLC, DSC, TGA, FTIR, Raman Spectroscopy, AA, X-ray diffraction, SEM, Dissolution, and Karl Fischer.

RESEARCH & DEVELOPMENT CHEMIST, UDL LABORATORIES, INC.

June, 1994 to October, 1996

Performed methods development and validation of analytical methodology for liquid formulations for ANDA submissions.

Prepared validation reports for ANDA submissions. Wrote and revised SOP material. Developed calibration procedures for FTIR with microscope,

DSC, and TGA. Trained R&D staff on the use of DSC, TGA, FTIR with

microscope, Dissolution, and Coulter particle size analyzer. Trained R&D and Q.C. staff on separations involving HPTLC and conventional TLC.

Performed maintenance on GC and established methods for quantitation using packed and capillary columns. Attended training seminars on HPTLC, FTIR, and DSC.

Promoted from quality control department to research and development department. Promoted once within the research and development department.

QUALITY CONTROL SHIFT LEADER, ZEPHYRHILLS BOTTLED WATER CO.

April, 1993 to June, 1994

Evaluation of product quality throughout manufacturing process. Development of raw material testing protocols.

Performed audits and on site inspections of proposed and current raw material vendors.

Trained in process qualification, validation, and certification. Sampling and biological testing of water. Certified in wastewater

management.

EDUCATION GANNON UNIVERSITY, ERIE, PA – BACHELOR’S OF SCIENCE

Chemistry

1988-1992

TEMPLE UNIVERSITY, PHILADELPHIA, PA – MASTERS

Quality Assurance and Regulatory Affairs

2005-2009

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REFERENCES AVAILABLE UPON REQUEST

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