Overview
Principal Scientist, CMC Lead – BioTalent
Location: Galway, Ireland
Schedule: Full-time, hybrid (3 days/week on-site)
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.
* Background in cell therapy or oncology (advantageous).
What’s on Offer
* Benefits: healthcare, pension, share scheme (eligibility after 1 year).
* Leadership role with high visibility and real scientific ownership.
* Opportunity to shape first-in-human trial strategy and grow a team.
Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
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