Dr. Seraphin Kuate, PhD, MBA, Rac
About Dr. Seraphin Kuate, PhD, MBA, Rac
Dr. Seraphin Kuate is the Director Global CMC Regulatory, Cell Therapy at Bristol Myers Squibb, with extensive experience in biologics, gene therapy, and regulatory affairs.
Professional Title and Current Role
Dr. Seraphin Kuate holds the position of Director, Global CMC Regulatory, Cell Therapy at Bristol Myers Squibb in the United States. In this role, he contributes his extensive expertise in scientific and regulatory affairs, focusing on cell therapy advancements, specifically CAR-T Cell Therapy and Lentiviral vectors.
Previous Professional Experience
Dr. Kuate's previous roles include serving as Senior Associate Director and Global Lead CMC RA, Biologics at Boehringer Ingelheim, where he worked from 2017 to 2020 in Ridgefield, Connecticut. He also worked as Associate Director at Oncobiologics Inc., concentrating on Global CMC and Clinical Regulatory Affairs for Biologics (Biosimilars) from 2015 to 2017 in Cranbury, NJ. Before these roles, he managed Clinical and CMC Regulatory Affairs at Biotest Pharmaceuticals Corporation from 2012 to 2015 in Boca Raton, FL and served as a CMC Reviewer for Biologics at the FDA from 2010 to 2012 in Bethesda, Maryland.
Academic and Teaching Roles
Dr. Kuate has an extensive academic background, having served as an Adjunct Associate Professor of Global Regulatory Affairs at the University of Maryland University College from 2014 to 2017. His educational journey includes obtaining a Ph.D. in Molecular Biology/Virology/Immunology from Ruhr-Universität Bochum and multiple Master's degrees in fields such as Epidemiology/Biostatistics, International Management, and Biochemistry.
Educational Background
Dr. Kuate's academic credentials include a Doctor of Philosophy (Ph.D.) in Molecular Biology, Virology, and Immunology from Ruhr-Universität Bochum and Master's degrees in Biochemistry from the University of Yaounde I, Epidemiology/Biostatistics from Universität Bielefeld, and International Management (MIM) from the University of Maryland University College. He also holds an MBA with a focus on Business Administration and Management from the same institution.
Certifications and Professional Skills
Dr. Kuate holds certifications in Regulatory Affairs (RAC) from the Regulatory Affairs Professionals Society (RAPS) and as a Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SoCRA). His expertise includes over 7 years of experience in scientific and CMC regulatory technical writing, a working knowledge of global regulatory submissions, and compliance with various regulatory guidelines such as GMP, GLP, and GCP (ICH E6).