About Us

Dr. Lee brings over a decade of CMC Analytical Development leadership experience across cell and gene therapies, biologics, and novel modalities. She holds a Ph.D. in Chemistry from Stanford University and completed postdoctoral research at UC Berkeley under Nobel Laureate Dr. Jennifer Doudna. Her experience includes serving as Senior Director at Kyverna Therapeutics, contributing to the company’s successful IPO in 2024, and as PTD ADQC Group Leader and Cell Therapy Analytical Development Functional Head at Genentech. She has supported 10+ INDs and BLAs across mAbs, bispecifics, ADCs, CAR-T, TCR-T, and viral/non-viral delivery platforms. Dr. Lee is an ASQ Certified Quality Auditor (CQA) and PDA Biopharmaceutical Advisory Board Member, and is specialized in navigating complex CMC development, quality, and regulatory requirements from early-stage development through commercialization, with particular expertise in potency bioassays, flow cytometry  assays, and molecular biology for regulatory submissions.