| John Harrahy, Ph.D. is a Senior Director in Sanofi’s Genomics Medicines Unit, leading the Viral and Nonviral Gene Therapy Bioanalytical Development team in Waltham, Massachusetts. His team supports early-stage CMC activities for viral and non-viral gene therapy modalities, including product characterization, process analytics, methods development, and release and stability testing. Prior to joining Sanofi, John worked in Amgen’s Pivotal Attribute Sciences group where the team supported late-stage MAA-enabling product characterization and method development activities for protein biologics, and he also led Amgen’s Analytical Target Profile workstream. Across his career, John has contributed to numerous IND and marketing applications, and external presentations on CMC control strategies and analytical methods. |