Lynne A. Ensor, PhD

Lynne Ensor, Ph.D., Deputy Director (Acting), Office of Process and Facilities (OPF), joined FDA in 1998. During her tenure in the FDA’s Center for Drug Evaluation and Research, Lynne worked in the Office of Generic Drugs for 15 years, briefly in the Office of Pharmaceutical Science, and currently serves in Office of Pharmaceutical Quality’s Office of Process Facilities. She has been highly involved in the Agency’s initial implementation of the Generic Drug User Fee Act (GDUFA I & II), currently serves on the Office of Pharmaceutical Quality’s Integrated Quality Assessment Governance Council, and is the executive sponsor of the OPF Process and Facilities Modernization Effort. Prior to being responsible for the oversight of OPF’s quality manufacturing and microbiology assessment of new, generic, and biologic drug products, Lynne’s responsibilities included supervising the OPF Division of Microbiology Assessment. Dr. Ensor earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park. In addition to Dr. Ensor’s regulatory experience at FDA, Lynne served as a clinical medical technologist at Roche Biomedical Laboratories, a post-doctoral research fellow at the University of Maryland at Baltimore’s School of Medicine, and a script consultant for the Discovery Channel.