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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