Dr. Claudia Lin is currently the head of Quality Assurance for Global Biologics Development at Bayer Healthcare, Berkeley. Her group is responsible for all aspects of Quality management for Bayer biotech products in clinical development through launch. She manages complex interactions between Development and Commercial Quality at the Bayer Berkeley site, as well as Development Quality for Biotech vs. Development Quality for small molecule globally.
Prior to joining Bayer, Claudia held various QA and QC positions with increasing responsibilities at Genentech ROCHE Biotech Division in global capacities, such as Clinical Product Quality Steward, Commercial Analytical Method Transfer, and Annual Product Review. She was instrumental in establishing the process and product quality monitoring systems for ROCHE commercial products, and contributed to the post-approval life cycle management strategy in the filing for Perjeta, a ROCHE biologics developed using QbD principals. Claudia got her Ph.D. in Cell and Molecular Biology from UC Berkeley, and has had extensive R&D experience in various therapeutic areas during earlier phases of her career.