Mantell Associates is partnered with an innovative Cell & Gene Therapy organisation who is seeking an experienced and strategic Senior Director of Manufacturing to lead the planning, execution, and optimization of manufacturing operations for cell and/or gene therapy products.
The role is critical to ensuring the delivery of high-quality, compliant, and scalable products to support clinical and commercial programs. The ideal candidate brings deep expertise in ATMP (Advanced Therapy Medicinal Products) manufacturing, including viral vectors, engineered cells, or plasmid DNA.
Senior Director of Manufacturing - Responsibilities:
- Lead day-to-day operations of GMP manufacturing for clinical and/or commercial-stage cell or gene therapy products
- Develop and implement manufacturing strategies aligned with corporate goals, ensuring timely production, compliance, and cost-efficiency
- Oversee tech transfer, scale-up, and process optimization efforts from development through GMP production
- Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements
- Build and manage high-performing teams across manufacturing operations, including upstream, downstream, fill/finish, and support functions
- Drive operational excellence initiatives to improve efficiency, yield, and quality
- Collaborate closely with QA, QC, MS&T, Supply Chain, Regulatory, and Development teams
- Manage relationships with CDMOs and other external manufacturing partners
- Lead readiness for health authority inspections, audits, and regulatory submissions
- Develop and manage budgets, headcount plans, and capital projects
- Implement and maintain robust manufacturing systems, documentation, and KPIs
Senior Director of Manufacturing - Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree (MS, PhD, MBA) preferred
- 10+ years of experience in biopharmaceutical manufacturing, with at least 5 years in cell/gene therapy or other ATMPs
- Strong knowledge of viral vector production (e.g., AAV, lentivirus), autologous or allogeneic cell therapy processes, or plasmid DNA manufacturing
- Proven leadership experience managing GMP manufacturing operations and teams
- Experience setting up or expanding GMP manufacturing suites (e.g., cleanroom design, facility start-up) preferred
- Prior work with CMOs or hybrid internal/external manufacturing models preferred
- Experience with MES, ERP, or digital manufacturing systems preferred
- Knowledge of Quality by Design (QbD) and Process Analytical Technologies (PAT) approaches preferred
- Familiarity with closed system processing, aseptic techniques, and automated cell culture technologies
- Experience with tech transfer, scale-up, and late-stage/commercial readiness is a plus
- Deep understanding of quality systems, regulatory requirements, and audit readiness
- Excellent communication, problem-solving, and project management skills
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
