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.