866-274-4009 Contact Us

Senior Scientist, Cell Therapy Process Development

King of Prussia, PA, US
Apply Now >

Summary

This role is responsible for supporting a team tasked with the tech transfer, process development, and process characterization of cell therapies.This role reports to the Director of Cell Therapy Process Development and will work in close collaboration with the Technology Transfer, MSAT, Analytical Development, Drug Product, and Manufacturing teams to execute process development, characterization and IND/BLA enabling studies. Execution of this role requires a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaborative skills. This position requires extensive knowledge of late-phase manufacturing, process characterization, IND and BLA enabling study design, and other activities as deemed necessary by program leadership.

Responsibilities

  • Plan and execute studies designed to drive successful process development and process characterization of cell therapy programs.
  • Support and oversee full or scale-down experiments to support process development and characterization of cell therapy manufacturing process.
  • Support technology transfer activities to ensure the successful and timely execution of manufacturing goals.
  • Identify collaborative business opportunities to increase process optimization, continuous process improvement, and overall success of the platform.
  • Utilize prior experience to identify and forecast phase specific process development strategies and develop new technologies.
  • Technical authoring of study protocols and reports, and other technical documents to drive successful technology transfer.
  • Provide expert scientific advice to client and cross-functional teams for successful execution of planned development studies.
  • Assess risk and opportunity to identify solutions to optimize to achieve departmental objectives while mitigating potential risks using effective cross-departmental collaboration.

Qualifications

  • MS (5+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic/autologous cell therapy technologies.
  • Extensive knowledge and experience in designing process development and process characterization studies of cell therapy or biologics manufacturing processes
  • Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies.
  • Prior experience in the technology transfer of new technologies is highly preferred.
  • Process characterization experience in cell or gene therapy processes is required.
  • Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management
  • Flexible for occasional weekend work

Senior Scientist, Cell Therapy Process Development

King of Prussia, PA, US
Apply Now >