Director Process Development

2 months ago

Boston, United States Barrington James Full time

We are seeking a leader to oversee the development of scalable manufacturing processes for iPSC-based cell therapy products. This role involves managing a team to optimize cell culture, differentiation, and GMP manufacturing processes throughout the product lifecycle. Key responsibilities include directing process design, scale-up, tech transfer, and providing technical oversight for external manufacturing partners (CDMOs).



Job Responsibilities:

  • As Director of Process Development you will lead the development and optimization of scalable processes for iPSC-based therapies.
  • Manage tech transfer to GMP manufacturing and provide oversight for CDMO activities.
  • Provide technical support to troubleshoot manufacturing issues during clinical production at CDMOs. Provide person-in-plant support, as needed
  • Responsible for managing a team to optimize cell culture, differentiation, and GMP manufacturing processes throughout the product lifecycle.
  • Mentor and manage the Process Development team.
  • Collaborate across functions to align process development with project goals.
  • Contribute to CMC strategy and regulatory submissions.


Job Requirements:

  • Masters degree with 12+ years of experience working in the Life Sciences industry including 5+ years in leadership.
  • Deep expertise in cell therapy process development, particularly with iPSCs.
  • Experience with GMP manufacturing, process scale-up, and regulatory submissions.
  • Strong problem-solving skills and the ability to work both independently and collaboratively.

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