Director/Associate Director, Cell Therapy CMC

3 weeks ago

Boston, United States QLD Biotherapeutics Inc Full time

Director/Associate Director, Cell Therapy CMC & ManufacturingWe 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 ResponsibilitiesLead/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.QualificationsPhD (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

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