James Hathcock, Ph.D.Sr Director, Regulatory and Validation Strategy at Pall Biotech
James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, which includes responsibility for the characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He currently leads the BPSA initiative on X-ray qualification 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>. He is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA. Since joining Pall in 2008, James has led material and performance qualification of medical and biotech components, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, 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. James enjoys coaching his daughters Lego Robotics team (NYC champions), reef tanking, and biking.