Rukman De Silva

Rukman De Silva, Ph.D. is currently working as a Policy Lead in FDA/CDER/OPQ/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. At Office of Biotechnology Products, he conducted review and inspection activities. In 2022, he joined FDA/CDER/OPQ/Office of Policy for Pharmaceutical Quality, where he involves in FDA policies and programs development activities. He 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 pharmaceutical products 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.