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