Marc Better, PhD

Cell Therapy and Biologics Process Development Expert

Career Highlights

  • Senior Consultant, Pharmefex

    • Cell therapy and biologics CMC consulting

  • More than 20 years of experience in cell therapy and biologics CMC; upstream, downstream, analytical and drug product process development; non-GMP and GMP manufacturing; Quality by Design; commercial manufacturing support; technology transfer, contract manufacturing of cell therapy products and recombinant proteins; and regulatory interactions

  • Senior Vice President, Product Science, Kite Pharmaceuticals

    • Led a group of 85 scientists and engineers responsible for process development,  technology transfer, manufacturing support and overall CMC activities for autologous and allogeneic engineered T cell therapeutics

    • Oversaw CMC operation teams, analytical development, process characterization and process validation activities

    • Delivered four engineered T cell products to US IND

    • Completed CMC activities leading to the successful US licensure of Yescarta, a first in class anti-CD19 CAR T cell therapy in October 2017

    • Extensive regulatory interactions worldwide, including US, EU, Canada, China and Japan

  • Executive Director, Process Science, Boehringer Ingelheim
    Pharmaceuticals Inc. 

  • Executive Director, Process Development, Amgen

Education

  • BS, Microbiology: Michigan State University

  • PhD, Biochemistry: Brandeis University

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