Mark Smith, MS ChE PMP

Mark Smith serves as Director of CMC and Project Management at Gate Neurosciences. Before joining Gate Neurosciences in 2020 Mr. Smith was most recently Director Manufacturing & Technical Services for animal vaccines at Eli Lilly’s Elanco division, leading development and technical transfer efforts of innovative vaccines to market launch. Previously, he was Sr. Project Manager with Eli Lilly leading Chemistry, Manufacturing and Controls teams in the development and launch of human and animal pharmaceutical products.

Mark has over 35 years of pharmaceutical industry experience in drug process development and manufacturing. He has overseen the process and product development of more than clinical candidates produced using organic chemistry, biotechnology, and biologics processes. Mark has led multiple collaborations with contract development and manufacturing organizations to successfully deliver innovative drug products and delivery devices for clinical evaluation through global market launch.  While at Lilly Mark led the CMC team for the early-phase development of mGluR2 antagonists for clinical evaluation in treating depression. In 2017 he founded Bioproduct Project Solutions, LLC to provide product development and management services to companies focused on pharmaceutical and veterinary product development and is serves as President and Managing Consultant.

Mark received a Master of Science (ChE) at The University of Missouri-Columbia and earned a BS in Chemical Engineering (Biochemical Engineering) from the University of Michigan.

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