Lori McCaig, Ph.D. is Director, Global Stability Program Management at Seagen, Inc, responsible for the stability standards, governance, and innovation in stability program design, data evaluation, and knowledge management from development through registration and product lifecycle. While providing program oversight and management to ensure stability for both pipeline and commercial products meets the highest industry standards (both technically and operationally), Lori collaborates externally to drive these industry standards toward science and risk-based approaches across all regions. Lori has served on the USP Biologics Stability Expert Panel and Physical Stability Subcommittee, is the current AAPS Stability Community Chair, has provided stability trainings to health authorities and university students, and collaborates in other industry stability workgroups. Before joining Seagen she was Head of Stability Program Management, Global Quality Control at Genentech/F. Hoffmann-La Roche Ltd, serving previously in other stability, laboratory and quality management roles. |