Principal Scientist – CMC Lead

7 days ago

Galway, Ireland BioTalent Full time

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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