Dr. Sau (Larry) Lee is the Deputy 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 (OBP, OLDP, ONDP and OPMA). 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.
Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, and Office Director. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance and policy. In 2016, Dr. Lee was appointed to the Senior Biomedical Research Service (SBRS) because of his extensive regulatory and scientific contributions to manufacturing science, complex drug substances and products, and emerging pharmaceutical technologies. Prior to joining the FDA, 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.