CMC Lead

An innovative cell therapy company is seeking a CMC Lead to drive Chemistry, Manufacturing, and Controls (CMC) as its lead therapy advances into first-in-human trials. This hands-on, senior role combines strategic leadership with practical execution, shaping the future of a pioneering therapy platform.

What you’ll do

• Lead and execute CMC activities across process, analytical development, GMP manufacturing, and tech transfer.
• Provide technical expertise and ensure high-quality CMC documentation, including GMP records, SOPs, and regulatory submissions.
• Manage CMC-related activities across internal projects and CDMO collaborations.
• Design, optimise, and transfer processes into GMP environments.
• Maintain detailed documentation and present findings to the leadership team.
• Collaborate with R&D, clinical, quality, and regulatory teams to meet project goals.
• Mentor and develop a small internal CMC team.

Who we’re looking for

• Advanced degree in Biotechnology, Cell Biology, Biochemical Engineering, or related field.
• Hands-on CMC experience in cell therapy, with strong GMP knowledge.
• Proven track record in tech transfer and regulatory submissions.
• Strong organisational and leadership skills.
• Based in Ireland or open to relocation.