Thomas R. Malefyt, Ph.D. – CMC, API and Drug Product
Thomas has over 35 years’ experience in management, oversight, and execution of Chemistry Manufacturing & Controls efforts in small and large pharmaceutical companies. He is responsible for the CMC pharmaceutical development programs for both large and small molecules, and at both early and late stages of development. Serving early-development pharmaceutical companies to utilize established Contract Development and Manufacturing Organizations to provide comprehensive CMC services including: planning, risk assessment, due diligence, management oversight for the manufacture of materials, and the development, transfer and validation of analytical methodologies; guidance for drug product formulation efforts, process development, GMP manufacturing, packaging, stability evaluation, and the preparation of CMC regulatory documentation.
Thomas was formerly Vice President of CMC Operations with Biotie Therapies, President and Chief Operating Officer of Admunex Therapeutics, Director of Roche Bioscience, Research Section Leader, Department Head, CMC Leader, Director of Syntex Research: Institute of Pharmaceutical. Sciences, Special Assistant to the President and COO of Syntex Corporation, Senior. and Assoc. Research Investigator of SmithKline and French Laboratories and Pharmaceutical CMC Consulting Services.
Thomas has a D. Physical Organic Chemistry, University of California at Santa Barbara, MS Biochemistry, California State Polytechnic University, Pomona, CA and BS Biology, California State Polytechnic University, Pomona, CA.