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.
