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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