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.