Director/Associate Director, Cell Therapy CMC & Manufacturing
QLD Biotherapeutics Inc
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.
#J-18808-LjbffrVacancy posted 19 hours ago
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