James Hathcock PhD

James Hathcock, PhD, is Senior Director of Regulatory and Validation Strategy at Cytiva, responsible for strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is currently an active supporting member of 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 containers; and has previously served as an expert panel member for USP <665> & <1665>.

Since joining Pall in 2008, now a part of Cytiva, James has supported business continuity and security of supply challenges, led material and performance qualification of medical and biotech components, and delivered relevant technical packages supporting regulatory filings. Before joining Pall, James served as a 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.