Grace Lee PhD Elevalue Consulting LLC
Dr. Grace Lee, PhD, is a highly experienced biotech leader with 15+ years of experience with technical domain knowledge and a strategic business mindset in drug development. She has a diverse scientific background covering oncology, immunology, genome-editing, and CMC knowledge with an end-to-end business mindset for drug development.
Over her career, Dr. Lee developed in-depth analytical and CMC expertise supporting IND to BLA of diverse modalities, including monoclonal antibodies, antibody-drug conjugates, bispecific molecules, and cell and gene therapies. Her experience includes product development planning, analytical method development, qualification/validation, technical transfer, setting up laboratories, designing end-to-end control strategies, and regulatory filing.
She previously served in various positions at Kyverna Therapeutics and Genentech. Dr. Lee was a senior director of analytical development at Kyverna Therapeutics, supporting autologous and allogeneic cell therapies. At Genentech, she supported biologics and cell therapy products from pre-clinical, clinical, and commercialization for potency assay development and other QC release and characterization assays. She led multiple cross-functional analytical and CMC teams.
Dr. Lee did her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley for regulatory RNA molecules. She holds a PhD in Chemistry from Stanford University and EMBA from Quantic School of Business.
Over her career, Dr. Lee developed in-depth analytical and CMC expertise supporting IND to BLA of diverse modalities, including monoclonal antibodies, antibody-drug conjugates, bispecific molecules, and cell and gene therapies. Her experience includes product development planning, analytical method development, qualification/validation, technical transfer, setting up laboratories, designing end-to-end control strategies, and regulatory filing.
She previously served in various positions at Kyverna Therapeutics and Genentech. Dr. Lee was a senior director of analytical development at Kyverna Therapeutics, supporting autologous and allogeneic cell therapies. At Genentech, she supported biologics and cell therapy products from pre-clinical, clinical, and commercialization for potency assay development and other QC release and characterization assays. She led multiple cross-functional analytical and CMC teams.
Dr. Lee did her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley for regulatory RNA molecules. She holds a PhD in Chemistry from Stanford University and EMBA from Quantic School of Business.