Steven Bowen, Ph.D.

Principal Consultant, CMC Biologics


Steven Bowen joined DataRevive (now ELIQUENT Life Sciences, Inc.) in 2022, following a distinguished career of 8+ years with the U.S. Food and Drug Administration (FDA). During his FDA tenure, Dr. Bowen served as both Investigator and Director of Team Biologics in the Office of Regulatory Affairs, Office of Biological Products Operations. He also worked in the Center for Drug Evaluation and Research (CDER), Office of Biotechnology Products as a CMC Reviewer and Team Leader.

Dr. Bowen’s career began in 2012 as a Post-Doctoral Fellow at the National Institutes of Health, Experimental Immunology Branch. There, he continued his Ph.D. thesis research project studying DNA damage response to V(D)J recombination in T lymphocytes. Dr. Bowen then transitioned to the role of CMC Reviewer at the Center for Drug Evaluation and Research (CDER) Office of Biotechnology Products. He served as a primary reviewer of CMC information submitted by sponsors in support of IND and BLA applications. Next, he became Team Leader and led a team of chemists, biologists, and microbiologists in reviewing CMC applications at all phases of product development. Dr. Bowen’s duties included serving as the Application Technical Lead (ATL) on multiple original BLA submissions, Immunogenicity Working Group (IWG) Co-Chair, and Inspection Coordinator.

In 2019, Dr. Bowen transitioned once again to the Office of Biological Products Operations where he served as Investigator, coordinating complex inspections and investigations including Mission Critical vaccine inspections during the COVID-19 pandemic. He most recently held FDA position was Director with Team Biologics in the Office of Biological Products Operations. He performed risk- based inspection planning for all domestic and foreign vaccine, cell and gene therapy, and in-vitro diagnostic device manufacturing facilities supplying the US market. Additionally, he was responsible for deciding inspection classification on FDA compliance activities.

Dr. Bowen is an Adjunct Assistant Professor of Biology at the University of Maryland, Global Campus. He earned his B.S. in Biology at Syracuse University and his Ph.D. in Molecular Microbiology and Immunology at University of Maryland, Baltimore.

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