Role: Principal Scientist, CMC
Location: London, UK (3 days per week on-site)

The Company
This pioneering biotech is developing a breakthrough neutrophil-based cell therapy platform to transform the treatment of solid tumours. Unlike patient-specific T-cell therapies, their approach is donor-derived, scalable, and consistent, enabling true manufacturing at scale. The therapy harnesses the natural tumour-fighting abilities of neutrophils, which can also be engineered to enhance anti-cancer activity.

The company is entering an exciting growth phase, with its first-in-human clinical trial scheduled to begin in Ireland within the next year. Manufacturing is supported by a leading CDMO partner, while the UK headquarters drive innovation, translational research, and CMC strategy. Backed by strong leadership, a clear clinical path, and cutting-edge science, this is a rare opportunity to contribute to the development of next-generation oncology therapies.

The Team
You will report directly to the CSO and initially line manage one scientist, with scope to expand the team as the company grows and new grant funding is activated.

The Opportunity
This is a high-impact role leading CMC strategy at a fast-growing biotech on the cusp of clinical development. You will shape GMP compliance, tech transfer, and regulatory governance, while building and leading a small but growing team. The role offers exposure to pioneering oncology science and the chance to directly influence the success of a first-in-human clinical programme.

Key Responsibilities
• Define and lead CMC activities and strategy for the neutrophil therapy platform
• Ensure GMP compliance across processes and documentation
• Oversee tech transfer to a specialist CDMO partner in Ireland
• Prepare and manage EU/IE regulatory submissions
• Work cross-functionally with translational and clinical teams
• Report directly to the CSO, providing regular strategic input
• Line manage and mentor scientists, with scope to expand the team

Requirements
• Significant CMC experience in cell therapy or advanced therapies, ideally oncology
• Strong track record of GMP compliance and governance in a biotech or CDMO environment
• Hands-on experience with CDMO oversight and successful tech transfer projects
• Solid knowledge of EU/IE regulatory requirements for CMC submissions
• Proven experience managing or mentoring junior scientists
• Based within commuting distance of London (3 days per week on-site)
• Willingness to travel occasionally to Ireland