Join a dynamic CMC team as a Director of Process Development to advance their iPSC-derived cell therapy pipeline. You'll lead the creation and execution of scalable manufacturing processes, from process development through GMP manufacturing, focusing on iPSC expansion and differentiation.
Responsibilities:
- Develop and oversee the process development strategy, ensuring alignment with CMC and overall project plans.
- Lead technical transfer, process scale-up, optimization, and GMP readiness, providing strategic oversight to external CDMOs.
- Manage and mentor the Process Development team, maintaining high standards.
Qualifications:
- PhD in Biological Sciences, Cell Biology, or Biomedical Engineering with 10+ years of experience, or a BS/MS with over 15 years in cell therapy process development.
- Proven expertise in iPSC process development and scalable stem cell culture systems, including bioreactors.
- Strong leadership skills with at least 5 years in a supervisory role, with a track record of successful tech transfer and GMP manufacturing oversight.
