Principal Scientist, Cmc

3 weeks ago

Galway, Ireland Biotalent Full time

Overview
Principal Scientist, CMC
Location:
Galway, Ireland (on-site, with occasional UK travel)
We're working with a pioneering cell therapy biotech developing the world's first neutrophil-based allogeneic platform to treat solid tumours.
Unlike patient-specific T-cell therapies, this approach is donor-derived, scalable, and consistent, enabling it to be manufactured at scale and delivered to patients more efficiently.
The therapy harnesses the natural tumour-infiltrating and tumour-killing abilities of neutrophils, which can also be engineered to enhance their anti-cancer activity.
The company is entering an exciting growth phase, with its
first-in-human clinical trial scheduled in Galway within the next 12 months
.
GMP manufacturing is supported by a specialist CDMO partner in Ireland, while the wider team drives innovation, translational research, and CMC strategy.
This is a rare chance to join at the point where science is translating directly into patient impact.
The Opportunity
This role is a bit different from a traditional lab-based process scientist role.
The platform and processes are already established.
Your first focus will be to lead and oversee
CMC strategy, GMP compliance, and tech transfer
to the CDMO in Galway.
You'll act as the scientific owner of the process, ensuring the CDMO is fully compliant, data and documentation stand up to regulatory review, and that manufacturing runs smoothly.
It's a senior role reporting directly to the CSO, with
line management of one scientist
at the start and scope to grow the team later in the year.
Longer term, as the company advances its neutrophil platform, this role will expand into more
process-focused development work
, shaping future therapies.
Key Responsibilities
Lead CMC activities and strategy for the neutrophil therapy platform
Ensure GMP compliance of process and documentation
Oversee tech transfer to the CDMO in Galway
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 expand the team
Requirements
5+ years' CMC experience in cell therapy or biologics (ideally oncology)
Strong GMP and regulatory expertise
Experience overseeing CDMOs and successful tech transfers
Knowledge of EU/IE regulatory requirements for CMC submissions
Leadership or line management experience
Based in/near Galway or willing to relocate, with some travel flexibility
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