Lynne A. Ensor, Ph.D.

Lynne A. Ensor, Ph.D.

Lynne A. Ensor, Ph.D.

Vice President, Technical

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.

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.

We are always available for a conversation.

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