Patricia Hughes, PhD

Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and is currently the Branch Chief of Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Product Quality in CDER/FDA. This Branch is responsible for the microbiology product quality assessments of all Biological License Applications submitted to CDER and for the pre-license and pre-approval inspections of biological manufacturing facilities. Dr. Hughes has over twenty years of industry experience in process development and manufacturing and has held various positions in the biotech industry ranging from Senior Scientist to Associate Director of Pharmaceutical Operations. She has been with the FDA for 20 years.