Mike Li | 李作斌简介
SUMMARY OF QUALIFICATIONS:
- More than 36 years pharmaceutical experience in the development of pharmaceutical products for various dosage forms (injectable, oral and transdermal).
- Extensive hands on experience in preformulation studies, analytical/formulation development, process development and scale up manufacturing.
- Experienced in development of drug products and regulatory requirements from IND-enabling studies to phase 3 and commercialization.
- Supported bioanalysis for preclinical and clinical studies.
- Prepared Chemistry, Manufacturing and Controls (CMC) documentation for two NDAs, more than 30 INDs and many ANDA submissions.
- Expertise in contract manufacturing and testing including vendor qualification, technology transfer and contract manufacturing for CRO/CMO in US and foreign countries.
- Played critical roles in helping three companies IPO and established licensing opportunities.
PROFESSIONAL EXPERIENCE:
Independent CMC Consultant 1/06 – now
- CMC development of early and late stage pharmaceutical products in various dosage forms or delivery systems.
- Selection, qualifying and managing CROs or CMOs for analytical development, bioanalysis, product and process development, manufacturing and distribution of clinical trial materials.
- Preparation of CMC documents for regulatory filings (INDs) or due diligence purposes.
- Performing GMP gap analysis, establishment of SOP and documentation systems.
Threshold Pharmaceuticals, Redwood City, California 3/03 – 1/06
Sr. Director of Product Development
Responsibilities included product, process and analytical development, manufacturing drug substance and drug product, QC/QA and documentation.
- Technology transfer and contract manufacturing of oral tablet and lyophilized drug products.
- Establishing API and DP specifications working with testing laboratories for release and stability testing.
- Packaging/labeling and distribution of clinical supplies
- Assembling CMC documents to support regulatory submissions
- Setting up documentation and SOP systems in compliance of cGMP requirements.
Matrix Pharmaceutical, Fremont, California 1990 – 2002
Director of Advanced Product & Process Development
Responsibilities included Quality Control, Manufacturing (1990-1992) and development of three anticancer drugs in parenteral dosage forms.
- Developed collagen-base semisolid injectable products and process to support clinical studies and enabled two NDA submissions.
- Transferred technology, analytical methods to QC/Manufacturing and contract manufacturers.
- Prepared technical and CMC reports to support IND and NDA submissions.
- Responsible for Pre-approval inspection (PAI) for R&D group.
Quad Pharmaceutical, Indianapolis, Indiana 1987 – 1990
Manager of Formulation Research. Responsible for development of parenteral generic drugs (small molecules and protein/peptides) in liquid, lyophilized and suspension dosage forms.
- Conducted preformulation and formulation studies.
- Process development, scale-up and manufacturing under GMP.
- ANDA submissions and response to FDA inquiry.
Bausch & Lomb, Rochester, New York 1986- 1987
Pharmacy Specialist in R&D Formulation Group.
Responsible for formulation research of lens care and eye care products.
- Evaluated ingredients and conducted preformulation studies.
- Developed and scaled up process for liquid and semisolid products.
LyphoMed Pharmaceutical (Fujisawa), Melrose Park, Illinois. 1983 – 1986
Development Chemist, Group Leader
Responsible for development of parenteral generic drugs (small molecules and protein/peptides) in liquid, lyophilized and suspension dosage forms, supporting ANDA submissions and commercial manufacturing
Austin Company, Des Plaines, Illinois 1982 – 1983
Process Engineer
Responsible for process development, instrumentation and control, equipment specifications, piping and sizing, material and energy balance, etc.
EDUCATION:
M.S. Chemical Engineering, University of Illinois at Chicago, 1982
M.S. Chemistry, Eastern Illinois University, Charleston, IL, 1979
B.S. Chemistry, Tunghai University, Taiwan, 1975
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