Deputy Director of Science, Office of Pharmaceutical Quality, CDER at FDA at FDA

Dr. Sau (Larry) Lee is the Deputy Super Office Director of Science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions. He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, CDER, and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval. He developed and established the Emerging Technology Program in CDER. He has been serving as a rapporteur for ICH Q13 on Continuous Manufacturing of Drug Substances and Drug Products.

Dr. Lee received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University.