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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