Head Of Cmc

Overview
Position:
Head of Chemistry, Manufacturing & Controls (CMC)
Job title:
Senior Consultant | Tech Ops | Pharma & Biotech
Location:
Galway, Ireland
Department:
Technical Operations / Product Development
Reports to:
Chief Executive Officer (CEO) or Chief Technical Officer (CTO)
Role Overview
We are seeking a highly experienced and strategic
Head of CMC
to lead all CMC activities for our innovative
cell therapy programs
.
Based in Galway, you will play a pivotal role in shaping and executing the CMC strategy into the clinic.
This is a senior leadership position requiring deep expertise in cell therapy manufacturing, regulatory compliance, and cross-functional collaboration.
Key Responsibilities
Define and lead the overall CMC strategy for the company's cell therapy pipeline.
Oversee process development, analytical development, technology transfer, scale-up, and manufacturing.
Build and manage high-performing CMC and technical teams, fostering a culture of scientific excellence and compliance.
Manufacturing & Operations: Establish and optimize cell therapy manufacturing processes, ensuring scalability, robustness, and cost-effectiveness.
Lead technology transfer to internal GMP facilities or external CDMOs.
Drive continuous improvement in process and analytical methodologies.
Regulatory & Quality: Ensure CMC compliance with global regulatory guidelines (EMA, FDA, ICH) for cell and gene therapy products.
Author, review, and approve CMC sections of IND/IMP D, BLA/MAA submissions, and regulatory interactions.
Partner closely with Quality and Regulatory Affairs to align on CMC strategy.
Cross-Functional Leadership: Collaborate with R&D, Clinical, Regulatory, and Commercial teams to enable seamless product development.
Support due diligence, partnerships, and investor interactions with CMC expertise.
Represent the company at regulatory meetings, scientific conferences, and with key stakeholders.
Qualifications & Experience
Advanced degree (PhD or MSc) in Cell Biology, Bioprocess Engineering, Biotechnology, or related field.
6+ years' experience
in biopharmaceutical development, with at least 3 years in cell therapy CMC leadership roles.
Proven track record in cell therapy process and analytical development.
GMP manufacturing and technology transfer.
Regulatory submissions and agency interactions.
Strong leadership skills with the ability to inspire and build teams.
Excellent strategic thinking, problem-solving, and communication skills.
Experience working with CDMOs, CROs, and global regulatory bodies.
Why Join Us?
Be part of a pioneering cell therapy company shaping the future of advanced therapeutics.
Lead critical CMC activities that directly impact patient outcomes.
Work in a collaborative, innovative environment in Galway's growing biotech hub.
Competitive compensation package with opportunities for growth and equity participation.
Job details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Project Management, Manufacturing, and Production
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing
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