Director Of CMC Gene Therapy

We are seeking a Director of CMC to lead the development and execution of CMC strategy across viral vector-based programmes. This is a highly cross-functional leadership role, interfacing with Process Development, Analytical, Regulatory, Quality, and external CDMO partners.

You will play a key role in advancing programmes from early clinical stages through to late-stage development, ensuring robust, scalable, and compliant manufacturing processes.

Key Responsibilities

• Define and lead CMC strategy for gene therapy programmes from preclinical/early clinical through to late-stage development
• Drive upstream and downstream process development, scale-up, and technology transfer to CDMOs
• Lead preparation and review of CMC sections for regulatory submissions (IND/IMPD/BLA/MAA)
• Establish and implement Quality by Design (QbD) principles, including identification of CQAs and CPPs
• Oversee process validation activities, including PPQ campaigns
• Manage CDMO selection, oversight, and performance, including tech transfer and manufacturing campaigns
• Lead cross-functional matrix teams, ensuring alignment on timelines, risks, and deliverables
• Identify and mitigate key CMC risks (e.g. scalability, assay readiness, comparability)
• Contribute to overall product development strategy and long-term manufacturing planning

Candidate Profile

• Significant experience in CMC development within cell & gene therapy, ideally with AAV and/or lentiviral vectors
• Proven track record advancing products through clinical development (Phase I–III), ideally toward commercialisation
• Strong expertise in process development, scale-up, and GMP manufacturing
• Experience with regulatory submissions (IND, IMPD, and ideally BLA)
• Demonstrated leadership of cross-functional and matrix teams
• Experience working with and managing CDMOs
• Strong understanding of QbD, DoE, and control strategies
• Excellent stakeholder management and communication skills