Shawn Gould is a Consumer Safety Officer with CDER's Office of Compliance. While at the FDA, Gould's worked on the pre-approval process for new and generic drugs with special emphasis on applications involving QbD and PAT concepts. He has served on working groups relating to Quality Systems, the PAI process, Strategic Planning, and Lean Operations within the agency. While working in industry, he led the development, scale up, and transfer the Anthrax Vaccine Adsorbed fermentation process to a newly constructed, multi-product facility. He also led the initiatives for the implementation of PAT as well as a QbD (design space) submission for a fermentation process. Over the past 16 years, Gould has held roles in development, manufacturing, quality, and validation for several companies within the pharmaceutical industry including biopharmaceutical, blood plasma fractionation, and topical/medical device firms. Previous major project assignments have encompassed fermentation, downstream protein purification, sterile filtration, aseptic processing, liquid/cream/lotion filling, facility design, process simulations, and statistical evaluation/modeling. Gould graduated from the University of Toledo with a Bachelors Degree in chemical engineering followed by his Masters Degree in chemical engineering from Washington University in St. Louis, Missouri.