JAMES KELLY WITCHER 99Any Street New York, NY 99999 999-999-9999 email@hotmail.com

SUMMARY Scientific Research Associate with over six years of research experience in both academic and the pharmaceutical industry. Strengths include technical expertise, organization skills, adaptability and ability to maintain productive relationships with colleagues. Contributions recognized for significant impact on the progression of projects. Strong scientific background includes: -Mammalian, insect, and ES cell culture -Stable and transient transfections -FACS Analysis/Sorting -ELISA Assay -Baculoviral expression -Microinjection (in D. melanogaster embryos)

-dsRNA preparation -PCR -Gel Electrophoresis/Western blotting -Protein extraction/purification -RNA interference -DNA Extraction

PROFESSIONAL EXPERIENCE AAA Corporation New York, NY Scientific August 2009-present

Served as liaison for international government agencies and the pharmaceutical industry.

Worked to establish parameters for management consideration of Process Analytical Technology to compendial policy.

Recommended experts in spectroscopy and analytical chemistry to populate General Chapter and Reference Standards Expert Committees.

Managed study as lead investigator on multi-laboratory project including U.S. FDA and private laboratory.

Supervised study for the development of Near Infrared Spectral Libraries on multiple NIR spectrophotometers

Developed, drafted and directed study protocol; drafted instrument and model standards for developing, maintaining, and transferring chemometric methods between laboratories.

Represented USP at PAT related symposia, conferences, and USP sponsored events.

Led efforts to develop, revise, and publish the final USP General Chapter on Near Infrared Spectroscopy

Oversaw 30 new and revised general and informational chapters.

Developed nine pharmaceutical water monographs, three general and informational chapters, and two new and revised general and information chapters.

. BBB Corporation New York, NY Scientific September 2008 June 2009

Establish and enforce internal standard business practices for the manufacture and release of pharmaceutical and cosmetic products, and ensure the production of safe products that meet their respective efficacy requirements as determined internally or by law.

Generate and maintain standard operating procedures, protocols, qualification and validation documents, chain of custody, and any other documentation necessary for regulatory compliance and efficient company operation.

Oversee manufacturing operations, both internally and at CMOs, to ensure compliance with regulatory requirements, current industry standards, and internal corporate standards.

Take the lead in establishing specifications for new products and reviewing/revising specifications for current products.

Ensure adequate personnel training under the scope of Quality Assurance and maintain the appropriate training documentation.

Manage product testing with outside contractors as needed.

Perform vendor and contract manufacturer site audits.

CCC Limited New York, NY Scientific September 2005 September 2008

Developed and maintained an application for estimating carbon emissions using Java

Designed a website for an online exam system using JSP, Servlets, MySQL and Apache Tomcat

Researched on Item Response Theory to provide an adaptive testing application

EDUCATION AND TRAINING B.S., Biochemistry, Cook College, New York University, New York, NY - 1999 TECHNICAL SKILLS Microsoft Office, Publisher, PowerPoint, Excel, Prism, SoftmaxPro, Odyssey and UNIX.