Patricia Hughes


Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University in Washington, D.C. and is currently the Sr. Scientific Advisor for the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently responsible for developing and implementing consistent microbiology product quality policies and standards in OPMA. She has held positions as Branch Chief and Team Lead overseeing microbiology product quality assessments of BLAs and the pre-license inspections of biological manufacturing facilities in CDER for 12 years. Dr. Hughes has also over twenty years of industry experience in process development and manufacturing and has held positions ranging from Senior Scientist in Process Development to Associate Director of Pharmaceutical Operations in the biopharmaceutical industry.