
Biotech Process Leader
3 days ago
This role involves leading and overseeing the development of a neutrophil-based allogeneic platform to treat solid tumours. Our approach harnesses the natural tumour-infiltrating and tumour-killing abilities of neutrophils, which can also be engineered to enhance their anti-cancer activity.
We are entering an exciting growth phase with a first-in-human clinical trial scheduled in Galway within the next 12 months. GMP manufacturing is supported by a specialist partner in Ireland while our team drives innovation and translational research.
You will report directly to the Chief Scientific Officer, with line management of one scientist at the start and scope to grow the team later in the year. Longer term, as we advance our neutrophil platform, this role will expand into more process-focused development work, shaping future therapies.
Key Responsibilities- Lead cell therapy activities and strategy for the neutrophil therapy platform
- Ensure Good Manufacturing Practice compliance of process and documentation
- Oversee tech transfer to a contract development and manufacturing organisation (CDMO) in Galway
- Write and manage regulatory submissions for European Union and Ireland markets
- Work cross-functionally with translational and clinical teams
- Report directly to the Chief Scientific Officer
- Line manage one direct report, with potential to expand the team
- 5+ years' experience in cell therapy or biologics (ideally oncology)
- Strong knowledge of Good Manufacturing Practice and regulatory requirements
- Experience overseeing CDMOs and successful tech transfers
- Knowledge of EU/IE regulatory requirements for submissions
- Leadership or line management experience
- Based in/near Galway or willing to relocate, with some travel flexibility
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2 weeks ago
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