Christopher Downey, PhD U.S. FDA

Christopher (Chris) Downey is the Director of the Division of Biotechnology Manufacturing Assessment in FDA/CDER’s Office of Pharmaceutical Manufacturing Assessment (OPMA), serving in this role since May 2022. His division is responsible for assessing CMC information related to microbiology and manufacturing and testing facilities for CDER-regulated biologics including monoclonal antibodies, other therapeutic proteins, and biosimilars. Prior to joining OPMA, he served in the Office of Biotechnology Products as a Review Chief from 2017 – 2022, a Team Lead from 2014 – 2017, and a Reviewer from 2012 – 2014. Dr. Downey holds a PhD in Biochemistry from the University of Colorado at Boulder was postdoctoral fellow at the University of Colorado and Georgetown University Medical Center.