CMC Lead, AAV Gene Therapy — Remote/Hybrid

Cpl Group; Greater London; Hybrid; GBP 111,000 - 141,000; Full time

Job summary

CPL Life Sciences is partnering with an innovative stealth-mode biotech to appoint a CMC Lead for an AAV gene therapy programme. You will own the CMC strategy and regulatory narrative, provide sponsor oversight of manufacturing and costs, and review all partner work.

Remote or hybrid setup with travel to Europe/US as needed. The role requires oversight of partner activities, experience with regulatory submissions and a track record in delivering CMC for advanced therapies.

Qualifications

• Experience with CMC strategy and governance for viral vector products.
• Proven track record in authoring Module 3 content and regulatory responses.
• Ability to manage manufacturing through CDMO/partners and maintain budgets.

Responsibilities

• Develop and govern the CMC development plan aligned to timeline and regulatory milestones.
• Review and approve partner manufacturing, analytical and stability plans and reports.
• Maintain CMC risk register, budgets, and readiness for inspections.
• Lead due diligence on partnerships focusing on process, analytics, capacity and cost of goods.
• Provide sponsor oversight of manufacturing quality, timelines and costs.
• Collaborate with data/science teams applying AI to process and data for control strategy.

Skills

CMC strategy

Regulatory CMC

Vendor management

GMP oversight

Stakeholder communication

Education

Life sciences degree

Job description

CPL Life Sciences is partnering with an innovative stealth-mode biotech to appoint a CMC Lead for an AAV gene therapy programme. You will own the CMC strategy and regulatory narrative, provide sponsor oversight of manufacturing and costs, and review all partner work.

Remote or hybrid setup with travel to Europe/US as needed. The role requires oversight of partner activities, experience with regulatory submissions and a track record in delivering CMC for advanced therapies.