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Location: London, UK (3 days/week on-site)
The Company
A pioneering cell therapy biotech is on a mission to transform the treatment of solid tumours through a unique allogeneic neutrophil-based therapy platform. Unlike patient-specific T-cell therapies, this approach is donor-derived, scalable, and consistent, enabling manufacturing at scale and efficient delivery to patients. The therapy harnesses the natural tumour-infiltrating and tumour-killing abilities of neutrophils, which can also be engineered to enhance anti-cancer activity. This makes the platform a differentiated strategy designed to overcome tumour resistance and improve outcomes.
The company is entering an exciting growth phase, with its first-in-human clinical trial scheduled in Ireland within the next 12 months. GMP manufacturing is supported by a specialist CDMO partner, while the UK headquarters drive innovation, translational research, and CMC strategy. With strong leadership, a visionary platform, and a clear clinical path ahead, this is a rare chance to contribute to next-generation oncology therapies at the point where science is translating into patient impact.
The Team
The role reports directly to the CSO and will initially include line management of one scientist, with scope to expand later in the year as grant funding is activated.
The Opportunity
This is a chance to lead CMC strategy at a high-growth biotech on the cusp of clinical development. You will directly shape GMP compliance, tech transfer, and regulatory governance while building and leading a small team. The role offers exposure to a cutting-edge oncology platform with significant potential impact.
Key Responsibilities
• Lead CMC activities and strategy for the neutrophil therapy platform
• Ensure GMP compliance of process and documentation
• Oversee tech transfer to a specialist CDMO partner in Ireland
• Write and manage EU/IE regulatory submissions
• Work cross-functionally with translational and clinical teams
• Report directly to the CSO
• Line manage one direct report, with potential to grow the team later this year
Requirements
• Strong CMC experience in cell therapy, ideally oncology
• Proven track record leading GMP compliance and governance in a biotech or CDMO environment
• Experience with CDMO oversight and successful tech transfer projects
• Knowledge of EU/IE regulatory requirements for CMC submissions
• Previous experience managing or mentoring junior scientists
• Based within commuting distance of London (3 days per week on-site)
• Willingness to travel occasionally to Ireland
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