Rukman S. De Silva, PhD U.S. FDA

Rukman De Silva, PhD 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 Programs (DIPAP), 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 control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAP, Branch II, where he conducts FDA policies and programs development activities related to pharmaceutical quality.

Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker in multiple conferences in the area of visible and subvisible particulates testing in past few years. He has published in peer reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also serves as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.