Kenneth G. Surowitz, Ph.D.
Specialties: Regulatory, CMC, QA/QC, Vaccines, Biologics
Biography
Dr. Kenneth Surowitz has served for 10 years as Adjunct Associate Professor in the Regulatory Affairs and Quality Assurance graduate program at the Temple University College of Pharmacy. He currently teaches a graduate degree course on “Vaccines: Regulatory and Quality Issues,” having previously taught a graduate course on “CMC for Biological Products”.
Dr. Surowitz has 35 years of experience in vaccines, biologics and biosimilars manufacturing, development and Regulatory Affairs, working at both established and early-stage organizations. He began his career in vaccines at Wyeth-Lederle Vaccines (now Pfizer), ultimately heading the Vaccine CMC RA department. He later served as VP of Regulatory/Quality at Progenics Pharmaceuticals focused on a Phase 3 melanoma vaccine program, and as Sr. Director RA (vaccines and biologics) at Merck & Co. Dr. Surowitz served as Vice President of the Global Biopharm RA Department at GlaxoSmithKline with CMC and clinical regulatory staff at sites in the US and UK, and served as VP Biologics at Dr. Reddy’s Laboratories interfacing with FDA and European authorities on biosimilar development programs. He finished his industry career as Executive VP of Regulatory Affairs at Accord Healthcare focused on biosimilars and complex generic drugs.
Dr. Surowitz holds a Ph.D. in Microbiology from The Ohio State University and an A.B. degree in Biology from Lafayette College.