Nicholas J. Casale

VP, Technical Operations, Amicus Therapeutics

Nick Casale is Novartis' Head of Strategy & Operational Excellence for the Cell & Gene Technical Development and Manufacturing organization in Morris Plains NJ. Novartis' Morris Plains Cell & Gene site produces KIMRYAH, the first FDA approved CAR-T cell therapy. Nick has over 28 years of Pharmaceutical and Biotechnology experience in Operations and Manufacturing Engineering. Nick was previously VP of Site Operations in Cambridge, MA for Brammer Bio LLC, a best-in-class CDMO specializing in viral vector gene therapy & modified cell therapy manufacturing. Prior to Brammer Bio, Nick was Sr. Director of Engineering for Biogen's commercial biologic drug substance manufacturing facility in Cambridge, MA. Prior to Biogen, Nick was the Global Director of Aseptic Process Engineering for Bausch & Lomb Pharmaceuticals having Engineering responsibility for (5) global manufacturing sites in the sterile ophthalmic and high volume aseptic-fill lens care businesses. Nick also has 20 years of global Engineering and Technical Operations experience with Johnson & Johnson across multiple divisions in OTC drug manufacturing, combination medical device and parenteral drug manufacturing. Nick earned a BS in Mechanical Engineering from Drexel University and holds several US patents for novel laser drilled rapidly disintegrating tablets which have been successfully marketed as an innovative OTC dosage platform for over a decade