Sau Lee, PhD

OPQ/CDER, FDA
Director & Emerging Technology Team Chair, Office of Testing and Research
Sau (Larry) Lee joined FDA in 2005 and has served as regulatory scientist, CMC team leaders, Associate Director for Science, and Deputy Office Director. Larry is currently the Director for Office of Testing and Research within OPQ, and he is also the chair for OPQ led Emerging Technology Program and led a multi-disciplinary team with representation from OPQ, OC and ORA to support the development, implementation and regulatory evaluation of novel technologies for pharmaceutical applications. He provides leadership in developing and implementing OPQ science and research programs to advance pharmaceutical quality and support quality assessment, inspection, surveillance and policy functions within FDA. In 2016, Larry was promoted to the Senior Biomedical Research Service (SBRS) because of his regulatory and scientific contributions to manufacturing science, complex drug substances and products, and emerging pharmaceutical technologies. Larry 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.