Matthew Schmidt

Matthew Schmidt is the Head of Drug Product Manufacturing at Ultragenyx’s Gene Therapy Manufacturing Facility (GTMF) in Bedford, MA. The greenfield site was opened in 2023 and is operational for clinical and commercial manufacture of Gene Therapy Drug Substance and Aseptic Fill/Finish. With more than 15 years of Drug Product Manufacturing experience across Radiopharmaceuticals and Gene Therapy between Lantheus Medical Imaging, and Ultragenyx, Matthew has represented the Manufacturing role during two site buildouts from design up through and including PAI. Through this experience and leadership role at the GTMF, Matthew understands the importance of integrated project teams that include end use stakeholders, and their influence on the success of projects from basis of design through construction, process development/qualification and commercial operations. Matthew has been involved in the Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE) for 10+ years and holds a Biology degree from Boston University.