Cmc Lead

2 days ago

Galway, Ireland Walker Cole International Full time

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 doLead 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 forAdvanced 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.If you'd like to find out more, please contact me or email

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