| Jess Lo Surdo, Ph.D. is a regulatory affairs (RA) Senior Manager at Amgen, Inc. focusing on Chemistry, Manufacturing and Controls (CMC) strategies for post-approval variations for biologics. Dr. Lo Surdo has been employed at Amgen, Inc for 4.5 years, leading commercial product CMC regulatory strategies through engagement with cross-functional teams, with recent focus on established conditions and ICH Q12 implementation through the International Society for Pharmaceutical Engineering (ISPE). Prior to Amgen, Dr. Lo Surdo worked at Bristol Myers Squibb for 2.5 years as an analytical product lead scientist leading analytical aspects of several pre-pivotal clinical programs. Dr. Lo Surdo began her career at FDA, working at the Center for Biologics Evaluation and Research in the Division of Cellular and Gene Therapies for 8 years, with initial focus on bioassay development for cell therapies and later increasing in scope as a staff fellow/product quality reviewer for cell therapy INDs. Dr. Lo Surdo holds a Ph.D. and Master’s degree in Bioengineering from the University of Pittsburgh, and a Bachelor of Science degree in Bioengineering from Syracuse University. |