Steven Wolfgang

Steven Wolfgang Ph.D. is a Consumer Safety Officer at the US Food and Drug Administration in the Center for Drug Evaluation and Research, Office of Compliance, Division of Manufacturing and Product Quality. He is involved in crafting pertinent CGMP guidance and policies as it pertains to drug manufacturing. Dr. Wolfgang came to FDA in 2005 as a chemist in the Office of New Drug Quality Assessment, after spending 15 years as an APIs and excipients product and process support specialist at Mallinckrodt Pharmaceutical Division of Tyco Healthcare (now Covidien). Dr. Wolfgang holds a postgraduate degree in Inorganic Chemistry and remains active in research on analytical characterization of pharmaceutical ingredients and the relationship of physicochemical properties of excipients to their functionality.