Director/Associate Director, Cell Therapy CMC & Manufacturing

QLD Biotherapeutics Inc; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

A biotherapeutics company based in Boston is seeking a Director/Associate Director to lead CMC strategy and manufacturing for cell therapy development programs. The ideal candidate has over 8 years of biotech experience, with a proven track record in advancing programs to clinical trials. This role offers an opportunity to significantly impact the transition from preclinical to clinical development in a collaborative environment.

Qualifications

• 8+ years of biotech/pharma experience required.
• 5+ years in cell therapy CMC leadership necessary.
• Hands-on experience with iPSC/MSC biology is essential.
• Proven track record of advancing programs into IND/clinical development.
• Deep knowledge of GMP regulations, regulatory expectations, and cell therapy manufacturing platforms.

Responsibilities

• Lead development and implementation of CMC strategy.
• Optimize processes for iPSC- or MSC-derived products.
• Contribute to regulatory filings for IND/CTA.
• Collaborate with CMC, R&D, QC, QA, and clinical teams across China and the U.S. for seamless preclinical to clinical transition.
• Support resource planning, budgeting, and project management for CMC deliverables.

Skills

Leadership

Project management

Cross-functional communication

GMP compliance

Education

PhD in Cell Biology, Immunology, or related field

MS in Cell Biology/Immunology/Bioengineering

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.