Lynne Ensor

Background

About Lynne Ensor

Dr. Ensor has been a consultant to the biopharmaceutical industry since 2019 and served 21 years at the U.S. FDA. She is currently a member of United States Pharmacopeia (USP) Microbiology Expert Committee, as part of the USP's 2020-2025 Council of Experts. Her experience as a regulator includes FDA/CDER experience in CMC review (CDER Master Reviewer for INDs, NDAs, BLAs, ANDAs and DMFs), policy development, and facility assessment (e.g, CGxPs), for both inspection and compliance. She also has 7 years' post-graduate experience in environmental and clinical microbiology research in industry. Her expertise includes sterile biopharmaceutical manufacturing and testing methods. She has experience in developing FDA policies, guidances, MaPPs, and SOPs. During her participation on both the senior leadership teams of the Office of Generic Drugs and Office of Pharmaceutical Quality, Lynne provided input on the negotiation of and implementation of the Generic Drug User Fee Act (GDUFA), as well as managing regulatory staff supporting PDUFA and BsUFA. She was highly involved in mitigating drug shortages and escalations in non-compliance (e.g, 483s, Warning Letters, consent decrees), previously as a regulator and currently as a consultant providing remediation strategies, with a focus on sterile and injectable products. In addition, she has extensive knowledge of USP, ICH Guidelines, ISO, AAMI, FD & C Act, 21 CFR 210, 211, 212, 314, 600, 601, 610 and other FDA regulations. Prior to joining PAREXEL, Dr. Ensor was the Acting Deputy Director for CDER/OPQ/Office of Process and Facilities (OPF) at the FDA.