Lynne Whitehead Ensor PhD

Dr. Lynne Ensor is the President and Owner of Ensor Pharma Biotech Consulting, providing strategic regulatory consulting to the pharmaceutical and biotechnology sectors. She is a seasoned expert in sterile product manufacturing, regulatory affairs, compliance, and remediation. Currently, Dr. Ensor is a member of the US. Pharmacopeia's Microbiology Expert Committee. Her previous consulting experience includes serving as the Senior Global Managing Director for Pharma Biotech Consulting and Life Sciences Training at NSF International, as well as a Senior Vice President and the Head of Global Compliance Consulting at Parexel International.

Before consulting, Dr. Ensor served for 21 years at the U.S. Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research (CDER). She served as the Deputy Office Director in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality (OPQ), on the senior leadership teams in OPQ and Office of Generic Drugs (OGD), as the Director for OGD/Office of Pharmaceutical Science/OPF's Divisions of Microbiology, and as a CDER Regulatory Master Reviewer. Her prior experience also includes Roche Biomedical Laboratories, the Discovery Channel, and the University of Maryland's School of Medicine. Dr. Ensor earned a B.S. in Biology and a Ph.D. in Microbiology from the University of Maryland.