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Key Personnel: Wei Chen, Ph.D.
Vice President of Manufacturing Operations
Dr. Chen is Vice President of Manufacturing Operations at Phage Biotechnology Corporation. Dr. Chen has over 15 years of experience in managing product development and CGMP manufacturing of biologic drug products through regulatory IND and NDA. It includes monoclonal antibody products, gene therapy viral/DNA vectors/vaccines, imaging/anti-cancer therapeutics, and recombinant proteins based therapeutics such as interferon, growth hormone, anti-infectious agents, and natural products.
Dr. Chen has led a number of projects of design-built and commissioning of low cost/fast track USFDA regulated CGMP facilities for clinical and commercial manufacturing of biopharmaceuticals. His regulatory experience includes CMC/IND submissions, FDA/California State FDB inspection for CGMP facility qualifications, clinical trial dosing, and product distribution.
His technical expertise includes process development, assay development, QC/ QA, validation for processes, assays, and equipment/facilities, formulation, fill-finish, tech transfer, and scale-ups, as well as managing CGMP operations for clinical to commercial supplies, staff training, shift and production planning, documentation, and product release.
Before joining Phage, Dr. Chen held manufacturing and drug product development positions at Bristol-Myers Squibb, Apollon/Centocor/Wyeth, Immunomedics, BioReliance, CoRatus/Baxter, Symbigene.
Dr. Chen has a Ph.D. in Bioreaction Engineering and Applied Microbiology from Nagoya University, Japan. He did his postdoctoral training at Yale Medical School, University of British Columbia, and UCLA in the areas of virology, bacteriology, genetics, cell biology, and bioprocessing/biomanufacturing.
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