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.
J-18808-Ljbffr
Create a job alert for this search
Director Cell Therapy • Boston, MA, US
Senior Director / Director Clinical Development
Director, Healthcare Solutions
Director, Regulatory Affairs CMC
Associate Director, Clinical and Translational Imaging
Director, Clinical Quality Assurance
Senior Director, CMC Process Development
Team Lead Manufacturing
Director of Endocrinology
Director, CMC Asset Lead (Rare Disease)
Director, Patient CRM, US Rare Diseases
Pioneering Medicines : Clinical Development Lead, Director
Director, Individual Markets Engagement & Operations
Medical Director Interventional Cardiology
Clinical Director
Director CMC Operations
Associate Director, Medicinal Chemistry
Medical Director (Physician)
