Cmc Lead

2 weeks ago

Galway, Ireland Biotalent Ltd Full time

CMC Lead (Principal Scientist)
Location:
Galway, Ireland
Schedule:
Full-time, hybrid (3 days/week on-site)
About the Company
A pioneering biotech is entering a pivotal growth phase as it prepares for its first-in-human clinical trial within the next 12 months.
With a novel cell therapy platform designed to transform the treatment of solid tumours, the company offers a unique opportunity to contribute to the next generation of oncology therapy at the point where science is moving directly into patients.
The Role
We're seeking a Principal Scientist to lead CMC activities and strategy.
This role will act as the scientific owner of the process, ensuring manufacturing records and outputs are GMP-compliant and ready for regulatory review.
You'll work closely with senior leadership, external manufacturing partners, and cross-functional teams to resolve technical challenges, drive strategy, and support trial readiness.
Key Responsibilities:
Lead CMC activities, governance, and regulatory strategy.
Oversee tech transfer to a CDMO partner.
Ensure compliance with GMP processes and documentation.
Write and manage EU/IE regulatory submissions.
Work cross-functionally with translational and clinical teams.
Line manage one direct report, with scope to grow the team.
Requirements:
Significant CMC experience in biotech or pharma.
Proven GMP compliance and regulatory expertise.
Experience managing CDMOs and leading tech transfers.
Prior line management experience.
Background in cell therapy or oncology (advantageous).
What's on Offer:
Benefits: healthcare, pension, share scheme
Leadership role with high visibility and real scientific ownership.
Opportunity to shape first-in-human trial strategy and grow a team.
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