Kelley Burridge

Dr. Kelley Burridge currently serves as a product quality team leader in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the US FDA. She leads a team of Office of Biotechnology Products (OBP) reviewers in the assessment of chemistry, manufacturing, and controls (CMC) information for pre- and post-market human therapeutic biologic drugs. Dr. Burridge is a member of the OPQ Emerging Technology Team and OBP Q12 working group.

Previous FDA positions include a chemistry reviewer in the Office of Life-cycle Drug Products (2014-2019) and lead reviewer of plastic and reconstructive surgery devices in the Center for Devices and Radiological Health (CDRH, 2010-2014). As a chemistry reviewer she assessed the quality of liquid-based drug products including topical semisolids, injectables, and peptides. Device review experience includes tissue adhesives, tissue markers, wound dressings, hemostatic agents, sutures, surgical meshes, and negative pressure wound therapies. Prior to joining the FDA, she obtained postdoctoral training experience and worked as an industrial process engineer. Dr. Burridge received a B.S. in Chemical Engineering from Cornell University and a Ph.D. in Biomedical Engineering from Boston University with special training in Biomolecular Pharmacology.


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