Rukman De Silva PhD U.S. FDA

Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality