Senior Director of Cell Process Development

1 month ago


City Of London, United Kingdom SLS Services Limited Full time

We are seeking a Senior Director of Cell Process Development to contribute to the advancement of next-generation CAR T-cell therapies for cancer treatment. The successful candidate will design and implement early-stage manufacturing processes and ensure a smooth transition to Late-Stage Process Development.

Key Responsibilities:
  • Develop and optimize early-stage manufacturing processes for CAR T-cell products from proof of concept through to early-stage process development.
  • Ensure smooth transition and delivery of processes suitable for Late Stage Process Development and eventual commercial launch.
  • Create and manage CMC work packages in support of regulatory filings from Phase 1 to CTA.
  • Oversee the process flow from Early to Late-Stage Development, supporting further process verification and validation.
  • Collaborate cross-functionally to leverage new T-Cell Therapy assets within the organization.
  • Lead interactions with internal translation/technology development groups and engage with external technology experts to align on innovative process strategies.

Requirements:

  • Proven experience in cell process development for biologics or cell therapies.
  • Strong understanding of CMC requirements and regulatory submissions.


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