Director / Associate Director, Cell Therapy CMC & Manufacturing
- Full-time
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
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.
We are an equal opportunities employer and welcome applications from all qualified candidates.
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