Director, Cell therapy Process Development
Position Summary
We are seeking a visionary and highly experienced leader to serve as Head of CMC & Manufacturing for advanced cell therapy development programs. This individual will be responsible for shaping and executing the Chemistry, Manufacturing, and Controls (CMC) strategy, overseeing process development and manufacturing operations, and ensuring successful advancement of programs from preclinical stages through IND submission and first-in-human clinical trials.
The ideal candidate will bring a proven track record of leading cell therapy programs through IND and into clinical development, deep technical expertise in iPSC or MSC-based platforms, and exceptional leadership skills to drive cross-functional collaboration across global teams.
Key Responsibilities
- Strategic Leadership
- Define and implement a comprehensive CMC strategy for cell therapy programs, ensuring alignment with corporate objectives and regulatory requirements.
- Provide thought leadership on manufacturing platforms, scalability, and innovation to support clinical and commercial readiness.
- Process Development & Manufacturing
- Lead process development, optimization, and scale-up for iPSC- or MSC-derived products.
- Oversee technology transfer to GMP manufacturing sites.
- Ensure robust and reproducible processes that meet quality and regulatory standards.
- Regulatory & Compliance
- Drive preparation and review of CMC sections of IND/CTA filings, ensuring timely and accurate submissions.
- Maintain deep understanding of global regulatory expectations for cell therapy products.
- Cross-Functional Collaboration
- Partner closely with R&D, Quality, Regulatory, Clinical, and Supply Chain teams to ensure seamless transition from preclinical to clinical development.
- Serve as a key liaison with external CDMOs and strategic partners.
- Operational Excellence
- Lead resource planning, budgeting, and project management for CMC deliverables.
- Establish and maintain a robust supply chain to support first-in-human studies and beyond.
- Team Leadership
- Build and mentor a high-performing CMC team, fostering a culture of innovation, accountability, and collaboration.
Qualifications
- Education
- Ph.D. (preferred) or M.S. in Cell Biology, Immunology, Bioengineering, or related discipline.
- Experience
- 8+ years of experience in biotech/pharma, with 5+ years in CMC leadership roles focused on cell therapy.
- Demonstrated success in advancing at least one cell therapy program from preclinical through IND and into clinical trials.
- Technical Expertise
- Hands-on experience with iPSC/MSC biology, process development, and GMP manufacturing.
- Deep knowledge of GMP regulations, regulatory expectations, and cell therapy manufacturing platforms.
- Leadership & Communication
- Proven ability to lead cross-functional teams in a fast-paced, dynamic biotech environment.
- Exceptional strategic thinking, project management, and interpersonal skills.
- Other
- Ability to thrive in a global, collaborative setting and manage complex programs with multiple stakeholders.
Why Join Us?
- Opportunity to shape the future of cell therapy and make a meaningful impact on patient's lives.
- Work in a high-growth, innovative environment.
- Competitive compensation, benefits, and career development opportunities.
FAQs
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