Francis Godwin

  PhotoFrancis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer in the chemical industry, designing, building, and optimizing chemical plants. He became certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He moved into pharmaceutical process validation where he worked on both batch and continuous processes for APIs and finished dosage manufacturing. Later he managed an analytical chemistry laboratory directly related with production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He served as a Team Leader dealing with international inspections and enforcement actions, as well as a Branch Chief overseeing Compliance’s reviews related to manufacturing sites named in pending ANDAs. Currently he is the Director of the Division of Drug Quality 2 (DDQ2), in the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug GMP cases.