Marc Doubleday

Marc Doubleday has more than 25 years experience in all aspects of biological product development, manufacturing, testing and related regulatory activities. This background encompasses blood products, therapeutic proteins, vaccines, cell therapy, and parenterals. Marc has a unique experience of starting and building a biological manufacturing operation from the ground floor. This included developing the facilities, procedures and human resources for process development, manufacturing, quality control, quality assurance, validation, engineering, materials handling, maintenance, calibration and safety and integrating these functions into an efficient, cGMP compliant operation.

Previously, Marc was the Chief Technical Officer for Northfield Laboratories, developer of a unique hemoglobin based oxygen carrier for the treatment of life threatening anemia. In this position he successfully designed and executed a pre-clinical toxicology program and validation studies for viral clearance and microbial retention. As CTO, he was a primary participant in successful meetings with FDA for pre-clinical toxicology, product characterization and CMC preparation. These activities culminated with Marc as a host of a successful pre-licensing inspection by CBER and the local district office.  

Prior to Northfield Laboratories, Marc worked as a Process Engineer for Davy McKee Corporation, a Technical Specialist for Millipore Corporation and a Process Engineer for Abbott Laboratories, Inc. 

Marc is an inventor on numerous patents for hemoglobin based oxygen carriers and a novel, hemoglobin based, media formulation for recovery and culture of pancreatic islet cells.  

Marc earned his Bachelor of Chemical Engineering degree at the University of Michigan and his MBA at the Kellogg School of Management at Northwestern University.