Christine A. Harman, PhD

Dr. Christine Harman is a CMC/facilities reviewer in the Division of Manufacturing and Product Quality (DMPQ), in the Office of Compliance and Biologics Quality/CBER/FDA. Dr. Harman received B.Sc. Degrees in Chemistry and Biology at Wright State University and received her Ph.D. in Biochemistry and Molecular Biology from Michigan State University. In 2009, she joined CBER in the Office of Blood Research and Review (OBRR) in which she performed regulatory review, in addition to conducting research. Her research area focused on antibody neutralization of the Hepatitis C virus, resulting in several publications including a first author publication. In 2014, Dr. Harman moved to OCBQ in which she is responsible for the review of INDs, license applications and supplements for a range of biologics, which include bacterial and viral vaccines, cellular and gene therapies, hematologic recombinants, blood fractionation products, and in-vitro diagnostic kits. In addition to regulatory review, Dr. Harman also performs inspections of biological manufacturing facilities.