Patricia F. Hughes, Ph.D. is the Team Leader in the Biotech Manufacturing Team in the Division of Manufacturing and Product Quality in the Office of Compliance in CDER, FDA. She has over twenty years experience in the Pharmaceutical/Biotech industry in fermentation & cell culture process development and manufacturing. In addition,
she has over twelve years of experience as a microbiology reviewer at the FDA, in CDER and CBER. Patricia holds a Ph.D. in Microbiology from Georgetown University.
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