Lynne Ensor PhD PAREXEL

Dr. Lynne Ensor is a Senior Vice President and the Head of Global Compliance Consulting for Parexel. She has been a consultant to the biopharmaceutical industry since 2019, with expertise in sterile product manufacturing, contamination control, and testing methods for both large and small molecule products. Lynne is currently a member of the U.S. Pharmacopeia Microbiology Expert Committee, part of the USP 2020-2025 Council of Experts. She was previously employed by the FDA for 21 years, having most recently served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER and prior to that the Director for the Divisions of Microbiology within OPF, Office of Pharmaceutical Science, and Office of Generic Drugs in CDER. Her prior experience includes Roche Biomedical Laboratories, the Discovery Channel, and the University of Maryland (UMD) at Baltimore’s School of Medicine. She earned her BS in Biology and PhD in Microbiology from UMD, College Park. Her professional activities include serving as a chairperson for 3 international pharmaceutical microbiology conferences, serving as a planning committee member for 11 scientific conferences, presenting 46 oral presentations to technical audiences (including frequently representing the FDA), and authoring 24 scientific publications.