CMC Lead – Cell & Gene Therapy

The Opportunity

We are partnering with a rapidly growing, innovation-led biotechnology organisation focused on advancing next-generation cell and gene therapies. With a strong pipeline and significant investment into viral vector platforms, the business is now looking to appoint a CMC Lead to play a critical role in driving development from early-stage through to commercialisation.

This is a high-impact position offering the opportunity to shape CMC strategy, lead cross-functional programs, and work at the forefront of AAV and lentiviral vector development.

 

The Role

As CMC Lead, you will take ownership of the Chemistry, Manufacturing & Controls (CMC) strategy across multiple programs, ensuring robust development, scalability, and regulatory alignment.

You will act as a key interface between technical, regulatory, and manufacturing teams, driving progress across development stages and ensuring successful delivery of key milestones.

Key Responsibilities

• Lead and define CMC strategy for viral vector-based therapies (AAV / Lentiviral)
• Oversee process development, scale-up, and tech transfer into GMP manufacturing
• Collaborate with MSAT, manufacturing, quality, and regulatory teams to ensure alignment
• Support and contribute to regulatory submissions (IND, IMPD, BLA)
• Manage external CDMOs and development partners
• Drive process optimisation, robustness, and scalability
• Ensure compliance with GMP standards and regulatory expectations
• Provide technical leadership across cross-functional project teams

Requirements

• Strong experience in CMC development within cell & gene therapy or biologics
• Proven expertise in viral vectors (AAV, Lentiviral preferred)
• Background in upstream process development, bioprocessing, or related field
• Experience with tech transfer, process scale-up, and GMP manufacturing
• Understanding of regulatory requirements and CMC documentation
• Demonstrated ability to lead cross-functional teams and manage complex programs

Desirable

• Experience working with or managing CDMOs
• Exposure to process validation and commercial manufacturing readiness
• Advanced degree (PhD or equivalent) in a relevant scientific discipline