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Grace Lee, Ph.D., MBA

Grace Lee, Ph.D., MBA

Sr. Consultant

Dr. Lee 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 from early to late stages. 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, including TCR-T and CAR-T therapies with different delivery vectors. Her experience includes analytical method development, qualification/validation, technical transfer, setting up laboratories, designing characterization and control strategies, authoring/reviewing GMP documents, and regulatory filing. She is experienced in due diligence and technical in-licensing.


Dr. Lee is also a founder of Elevalue Consulting LLC. Prior to her consulting career, she was a senior director of analytical development at Kyverna Therapeutics, supporting autologous and allogeneic cell therapies with a successful IND submission.

Before that, Dr. Lee was the head of analytical development of the cell therapy engineering and development department and a group leader in the analytical development and quality control department at Genentech. She supported >10 biologics and cell therapy products from pre-clinical, clinical, and commercialization for potency assay development and other release and characterization assays. She led multiple cross-functional analytical and CMC teams.

Before joining Genentech, Dr. Lee was a postdoctoral fellow in Molecular and Cell Biology at the University of California, Berkeley. She worked on miRNA/siRNA and CRISPR Csy4 projects in Dr. Jennifer Doudna's lab. She holds a Ph.D. in Chemistry from Stanford University and an EMBA from Quantic School of Business and Technology.

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