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Debra Barngrover, PhD, is a senior consultant with the Biologics Consulting Group and has over 30 years of experience in the biopharmaceutical industry. At BCG, she has authored and reviewed several CMC BLA and IND submissions, conducted facility audits and due diligence visits, and prepared regulatory and development strategy plans.
Prior to BCG, Ms. Barngrover was vice president, technology development, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, as well as managing the technology development group responsible for development of more than 15 small molecule, protein and viral vector products. She has provided managerial leadership to process development, analytical, formulation development, project management, manufacturing, package and label engineering and risk management functions.
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