We are seeking a Senior Director / Executive Director, Cell Process Development to join our team and 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.
Qualifications:
Proven experience in cell process development for biologics or cell therapies.
Strong understanding of CMC requirements and regulatory submissions.
Excellent cross-functional collaboration and leadership skills.
Apply now to join a cutting-edge team in transforming cancer treatment through innovative T-cell therapies.