Rukman De Silva PhD U.S. FDA

Rukman De Silva, Ph.D. is currently working as a Policy Lead at 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 Policy and Communication (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. Following a brief 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 development of FDA policies and programs pertaining to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2019 and 2024. He has been an invited speaker in multiple conferences in the area of visible and subvisible particulates testing in pharmaceutical products past few years. He has published in peer reviewed journals on the subject of subvisible particulate testing in biotherapeutics. He also serves as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.