Organic Chemist in Pharmaceutical Development and Quality Compliance

Expertise

• Pharmaceutical development and quality compliance.
• Biopharmaceutical and medical device development.
• Development of pharmaceutical activates related to controlled release drug elute stent medical devices.
• Contract Service Provider (CRO) management.
• API development, vendor selection and CMC submission.
• Bioanalytical method development, validation and testing.
• Regulatory requirements and compliance, identify pathway, development strategy, define scope and preform gap analysis.
• Regulatory submissions and preparations (IND, amendments, NDA) for CMC.
• Clinical trial management and trial supply chain management.
• Inventor with 16 patents disclosures related to drug delivery devices, diagnostic devices and drugs.
• Pre-clinical data review.
• Method validation and transfer.

Experience

Industrial Experience, Present

• Over 17 years of experience in pharmaceutical development and quality compliance.
• Providing Director and Manager positions at large and small companies.
• Broad background in pharmaceutical product development and process optimization.
• Leadership roles developing pharmaceutical products ranging from preclinical to NDA for both biologics and small molecule.
• Successful development and maintenance of clinical trial supply chain, including drug substance and drug product manufacturing/sourcing, testing and release, packaging, labeling, and distribution.
• Extensive experience in selecting auditing, qualifying, and managing CROs/CMO with U.S. and oversea; including management of technical issues, quotations, contractor selection, evaluation and scheduling.
• Trial manager for clinical trial and study director for animal studies conduction PK, dosing.

Undisclosed Company, Director, Analytical Development, 2006 - Present

• Responsible for all aspects of analytical work including method development, validation, stability study, batch release, and specification development.
• Responsible for preparation of several CMC sections of INDs and annual reports.
• As Trial Manager responsible for clinical trials.

A.P. Pharma, Inc., Director, Analytical Chemistry, Redwood City, CA, 2004 - 2005

• Responsible for all aspects of analytical method development and QC testing (polymer based drug product).
• Managed both method development and QC groups.
• Oversaw method development, validation, transfer, stability program, clinical release and routine QC analysis.
• API characterization, development, and qualification.
• Managed analytical activates for pre-clinical and clinical development including bio-analytical studies: pre-clinical characterization, polymer characterization, polymorphic screening, container evaluation, and drug formulation.
• Built the high performance team and streamlined the analytical operations.
• Reduced the turnaround time from three months to 5 days, and maintain it through the year. Improve the quality of testing.

Pain Therapeutics, Inc., Associate Director, QC, South San Francisco, CA, 2003 - 2004

• Responsible for QC release and stability study.
• Provided leadership in selecting methods, techniques, and evaluation criteria.
• Daily contract service management; managed one million dollars budget.
• Established stability programs (Phase III/registration stability studies).
• Generated product specifications (Chairman of Specification Board).
• Released in-process, intermediates and final products.
• API and raw material development and vendor qualification.

Medtronic, QA Laboratory Supervisor and Sr. QA Engineer, Santa Rosa, CA , 2001 - 2003

• Managed pharmaceutical activates to support the development of the controlled release medical devices (drug elute stent).
• Developed methods, selected techniques, and defined evaluation criteria to support early stage drug screening and formulation development.
• Built the quality system and organization to support the clinical program. Built the first pharmaceutical analytical lab in Medtronic AVE. Hired chemists and grew the laboratory to full functional test lab within 6 months.
• Determined in vivo and in vitro elution rate in polymer matrix formulation product.
• Determined the physical and chemical properties of API, polymers and formulation products.

Chromatography, Inc., HPLC Lab Manager, Newport, Delaware, 1999 - 2000

• Provided technical and marketing support for Agilent's HPLC columns.
• Provided technical support for customers in pharmaceutical industry.
• Conducted method development based on the fundamental mechanism of the columns, mobile phase and organic compound interaction.

T.W. Tunnel, Sr. Consultant for Johnson & Johnson, Port Washington, PA, 1998

• Provided consultation service for phase III registration stability studies and NDA.

Lonza, Inc., Project Champion, analytical chemistry, Conshohocken, PA, 1996 - 1998

• Managed analytical activities to support new product introduction at commercial production environment.
• Managed scope, schedule and resource allocation for new product introduction.
• Developed specifications for raw material requirements and conducted audits.
• Responsible for method development, validation and transfer.

Compton & Knowles Co, Research and Development Chemist, Reading, PA, 1993 - 1996

• Responsible for new product development.
• Developed new products and new formulations.
• Full life cycle product development including laboratory synthesis, scale up, process development and production introduction.

Honors & Publications

Academic and Professional Affiliations

• Post-doctoral Research, The Picower Institute for Medical Research (North-Shore Hospital), Manhasset, NY: Drug discovery research for Diabetes, Alzheimer and Malaria diseases.
• American Chemical Society

Publication and Patents

• Author of ten presentations and several papers.
• Inventor of 16 patents disclosures including drug delivery devices, drug, and diagnostic devices.

Education

• Ph.D. Organic Chemistry, The American University, Washington, D.C.
• MBA Sonoma State University, Rohnert Park, CA
• M.S. Chemistry, The American University, Washington, D.C.
• B.S. Chemical Engineering, Beijing Institute of Industry, Beijing, China