Speakers

Shannon Heine is a Senior Pharmaceutical Scientist in the Division of Pharmaceutical Manufacturing Assessment I, within the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Pharmaceutical Quality (OPQ), at CDER/FDA. Shannon joined the FDA in 2019 and serves as a product quality microbiology, manufacturing process, and facility primary assessor for both large and small molecules. She is primarily responsible for evaluating sterility assurance information provided in support of ANDA, BLA, and NDA submissions. Prior to joining the FDA, Shannon was a Research Associate in the Department of Pediatrics, Center for Vaccine Development, University of Maryland, School of Medicine where she performing development and pre-clinical vaccine testing. She received her Ph.D. in Microbiology, Immunology, and Tropical Medicine from The George Washington University.