Jennifer Swisher

Jennifer Swisher is a Review Chief in the Division of Biotechnology Review and Research IV (DBRR4) of the Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Quality (OPQ), CDER, FDA. OBP is responsible for the assessment of product quality information submitted in regulatory applications for therapeutic proteins, including new molecular entities and biosimilars. She received her bachelor’s degree in Molecular Biology from Princeton University and obtained her Ph.D. in the department of Biochemistry and Molecular Biophysics at Columbia University, followed by a postdoc in the Cellular Immunology Section of NIDCR, NIH. During her time at the FDA, she has been a researcher-reviewer, Team Lead, and Review Chief and has served extensively on internal and external working groups and committees, with particular focus on antibody effector function as well as the conduct of compatibility/in-use stability studies to support the safe administration of highly potent products.