James Hathcock, PhD

James Hathcock, PhD is Director of Regulatory and Validation Strategy at Cytiva, responsible for the strategy to support safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is currently an active supporting member to BioPhorum, BPSA, ASTM, ASME-BPE, PDA and ISO. He also leads the BPSA initiative on X-ray security of supply for single-use disposables, the BioPhorum Community of Practice for Extractables and leachables, and the ASME-BPE task group on single-use biocontainers; and has previously served as an expert manel member for USP <665> & <1665>. Since joining Cytiva in 2008, James has led material and performance qualification strategies for medical and bioprocessing materials, coordinated relevant technical packages and briefings supporting regulatory filings, and supported business continuity and security of supply challenges. Prior to his experienced with Cytiva, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery.