Sean Marcsisin FDA

Sean Marcsisin has been with the Food and Drug Administration (FDA) for four years with the Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs. Sean serves as an investigator in Pharmaceutical Quality and as a subject matter expert on current good manufacturing practices (cGMP) for pharmaceuticals. Sean’s roles and responsibilities include planning, conducting, and leading cGMP and Pre-Approval inspections of pharmaceutical and biopharmaceutical firms, both foreign and domestic. Prior to joining the FDA, Sean served on active duty with the U.S. Army as a scientist, where he contributed to the pharmaceutical development of therapies for neglected tropical diseases.