James currently serves at the Chief Technical Officer of Tr1X, Inc. where he has responsibility over all CMC-related activities including Process and Analytical Development, Manufacturing, Quality and Supply Chain. While at Tr1X, James has led the development, tech transfer and manufacturing of two allogeneic Treg cell therapies that are currently being evaluated in the clinic for autoimmune disorders.  James has 30+ years of operational experience across a wide range of disciplines including R&D, manufacturing, quality operations, and marketing and sales. He previously served as VP of Technical Operations at Sonoma Biotherapeutics where he supported development of biologic and cell therapies targeting autoimmune disorders. Prior to joining Sonoma, James led the clinical manufacturing division at the Fred Hutchinson Cancer Center where he had direct responsibility for biologic and cell & gene therapy products. James has an MBA from Rivier University and a BS in Microbiology from Michigan State University.