Dr. Gutierrez-Lugo is a Product Quality Review Chief in the Office of Biotechnology Products (OBP), OPQ, CDER, FDA. Prior to joining the FDA in 2008, Dr. Gutierrez-Lugo conducted postdoctoral research at the NIH and at the University of Arizona. She holds a Ph.D. in Chemical Sciences (Pharmacy) from the National Autonomous University of Mexico.