Jia-Hwa Fang Joins SRI Biosciences as Director of Clinical Manufacturing
Menlo Park, Calif. — December 7, 2011 —Jia-Hwa Fang, Ph.D., has joined SRI Biosciences as Director of Clinical Manufacturing. In this new role, he will lead a team to transfer and scale-up R&D, Good Laboratory Practice (GLP), and pilot formulations for early stage clinical trial materials in compliance with Good Manufacturing Practices (GMP). He will be responsible for developing technical, quality, and project specifications for studies in SRI’s pharmaceutical clinical manufacturing facility.
Dr. Fang has a broad range of expertise in process development and manufacture of small molecules and biologics for drug products such as parenterals, tablets, capsules, transdermals, and topicals. He has extensive experience in all phases of clinical manufacturing, including process development, scale-up, trouble-shooting, and validation. In addition, he has worked in technology and manufacturing process transfer for late stage products. He has authored and reviewed regulatory documentation and submissions such as manufacturing and validation protocols and chemistry, manufacturing, and controls sections for IND and NDA filings in the United States and EMA filings in Europe.
Dr. Fang has more than 20 years industry experiences at small and large biotech companies. Prior to joining SRI, he was a consultant for Impax Laboratories, Inc. Previously, he was director of formulation and manufacturing at CMC Technology Management Group and responsible for formulation and manufacturing at APT Pharmaceuticals. Earlier, he was a senior scientist at Novartis, Chiron Corporation, and TheraTech Inc. He has successfully developed and manufactured microparticles under aseptic conditions for Phase I clinical trials, including a proprietary adjuvant manufacturing process for Fluad® vaccine and transdermal formulations for Theraderm®.
Dr. Fang has a Ph.D. from the University of Missouri-Rolla and completed a postdoctoral fellowship at Clarkson University, where he developed and transferred a process for the manufacturing of perfluorohydrocarbon blood substitute emulsions.
