Kate S. Lee

Kate S. Lee is an accomplished quality assurance professional with extensive experience in the biotechnology and pharmaceutical industries. Currently serving as Associate Director of Quality Assurance at Xencor, Kate provides quality oversight for cGMP manufacturing and testing. Previously, Kate held key roles at Takeda (formerly Shire Plc), focusing on global process validation strategies and managing validation activities for product launches and regulatory commitments. At Shire, significant contributions included developing a CPV strategy that greatly improved process efficiency. With a strong background at Baxter Healthcare, Kate led numerous quality improvement initiatives, including CAPA investigations and Lean implementations, resulting in considerable cost savings and enhanced manufacturing processes. Kate's early career included research at Lawrence Berkeley National Laboratory, where analytical expertise was applied in structural biology. An educational background in Molecular and Cell Biology from the University of California, Berkeley, complements Kate's robust professional portfolio.