Lynne Ensor, Ph.D.

Lynne has 21 years U.S. FDA/CDER experience in CMC review (CDER Master Reviewer for INDs, NDAs, BLAs, ANDAs and DMFs), policy development, and facility assessment (e.g., CGMPs), for both inspection and compliance. She also has 7 years post-graduate experience in environmental and clinical microbiology research in industry.

Lynne serves on the U.S. Pharmacopeia’s Microbiology Expert Committee (part of USP’s 2020 2025 Council of Experts). The Microbiology Expert Committee is responsible for developing modern microbiological methods related to cell and gene therapy, rapid testing, and sterility testing. Its standards impact a large number of medicinal and health product and are relevant in an evolving global environment. 

Work Experience 

Her expertise includes sterile biopharmaceutical manufacturing and testing methods. She has experience in developing FDA policies, guidances, MaPPs, and SOPs. 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, Lynne was the Acting Deputy Director (GS-15) for CDER/OPQ/Office of Process and Facilities (OPF) at the FDA.

Education

Lynne received her Ph.D. in Microbiology and B.S. in Biology from the University of Maryland, College Park.