James Hathcock (PhD)
Sr Director, Regulatory and Validation Strategy
James Hathcock’s role 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. He has previously served as an expert panel member for USP <665>&<1665> and is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA.
Senior Manager - Quality for Suppliers and Incoming Materials, GSK Vaccines
Christelle Marcoux from GSK Vaccines is a Bioengineer specialized in brewing and pharmaceutical industries. She made her career in the single-use systems spending 20 years on commercial support and services, development, validation and implementation strategy for several companies like Merck and GSK Vaccines. In January 2015, she joined GSK Vaccines, where she worked as Head of Single-Use System Technologies in Global MSAT IM before moving to the Quality for Suppliers and Incoming Materials Department as Senior Manager in November 2021.