Position Summary

We are seeking a highly experienced and visionary leader of CMC & Manufacturing to lead our cell therapy development programs. The successful candidate 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

• PhD (preferred) or MS in Cell Biology, Immunology, Bioengineering, or related field.
• 8+ years of biotech/pharma experience with at least 5 years in cell therapy CMC leadership.
• Hands-on experience with iPSC/MSC biology, process development, and GMP compliance.
• Proven track record of advancing programs into IND/clinical development.
• Deep knowledge of GMP regulations, regulatory expectations, and cell therapy manufacturing platforms.
• Excellent leadership, communication, and cross-functional team management skills.
• Strong interpersonal and communication skills; ability to thrive in a fast-paced, collaborative biotech environment.
• Strong leadership, project management, and cross-functional communication skills.