Director / Associate Director, Cell Therapy CMC & Manufacturing

Director / Associate Director, Cell Therapy CMC & Manufacturing

We are seeking a highly experienced and visionary leader of CMC & Manufacturing to lead our cell therapy development programs. The successful candidate will help lead CMC strategy, manage process development and manufacturing activities, and play a key role in advancing programs into first-in-human clinical trials. This role requires demonstrated success in bringing at least one cell therapy program from preclinical through IND and into clinical trials.

Key Responsibilities

• Lead / support the development and implementation of CMC strategy for cell therapy programs.
• Lead process development and optimization for iPSC- or MSC-derived products and drive process development, scale-up, and tech transfer.
• Contribute to regulatory filings (CMC sections of IND / CTA).
• Collaborate with CMC, R&D, QC, QA, and clinical teams across China and the U.S. to ensure a seamless transition from preclinical to clinical development.
• Support resource planning, budgeting, and project management for CMC deliverables.
• Provide strategic leadership to ensure clinical readiness and robust supply chain for first-in-human studies.

Qualifications

We are an equal opportunities employer and welcome applications from all qualified candidates.

#J-18808-Ljbffr