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Director/Associate Director, Cell Therapy CMC & Manufacturing
Director/Associate Director, Cell Therapy CMC & ManufacturingQLD Biotherapeutics Inc • Boston, MA, United States
Director / Associate Director, Cell Therapy CMC & Manufacturing

Director / Associate Director, Cell Therapy CMC & Manufacturing

QLD Biotherapeutics Inc • Boston, MA, United States
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

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

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    Director Cell Therapy • Boston, MA, United States

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