Jason M. Warfel, PhD

Jason Warfel, PhD is a Scientific Director in Commercial Analytical Strategy at Bristol Myers Squibb (BMS), where he chairs the Commercial Specifications Committee and leads the development of specifications strategies across a diverse commercial biologics portfolio. He is a recognized expert in science and risk-based specifications and actively participates in EFPIA, ISPE, and IQ Consortium industry working groups advancing this area. Jason is a frequent invited speaker and panelist at international conferences and is currently co-authoring a book chapter on the application of Quality by Design principles to science and risk-based specifications. Previously, he served as the strategic analytical lead for multiple biologics programs at BMS, overseeing end to end analytical strategies, and achieving global approval for 3 new marketing applications. Prior to joining BMS, Jason was a Staff Fellow and CMC regulatory reviewer at FDA/CBER. He has authored more than 20 scientific publications and received the Maurice Hilleman Award from the National Foundation for Infectious Diseases. Jason holds a PhD in Microbiology and Immunology from Georgetown University.