Madushini Dharmasena PhD U.S. FDA

Madushini Dharmasena PhD

Madushini Dharmasena PhD U.S. FDA Senior Pharmaceutical Quality Assessor, OPQ, CDER

Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire.