Ellen A. Huang U.S. FDA

Ellen Huang is a Senior Advisor in the Office of Biological Products Operations (OBPO) in the Office of Medical Products and Tobacco Operations (OMPTO), at FDA’s Office of Regulatory Affairs (ORA), where she serves as the principle advisor providing direction and oversight on a broad and complex range of programs related to the regulatory enforcement of biological products. Her responsibilities include providing professional expertise, serving as a member of the Program Director’s senior management team and formulating program goals and operating policies.

Prior to joining ORA, Ellen worked for ten years in FDA’s Center for Biologics Evaluation and Research (CBER). Most of her time in CBER was spent as a Team Leader and Reviewer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ). Her primary responsibilities in DMPQ included providing technical expertise to the division and reviewing facility and equipment information in license applications and supplements for biological products. Ellen also conducted pre-license and pre-approval inspections of biological manufacturing facilities.

Before joining the FDA, she worked for six years in the biological, pharmaceutical, and medical device industries. Ellen received her B.S. in Industrial and Manufacturing Engineering from The Pennsylvania State University.