CMC Lead, AAV Gene Therapy | Global Strategy & Oversight

Cpl Life Sciences; United States; Hybrid; GBP 120,000 - 180,000; Full time

Job summary

Cpl Life Sciences is partnering with an innovative stealth-mode biotech to appoint a CMC Lead. You will take sole sponsor-side responsibility for chemistry, manufacturing and controls on the programme, owning the CMC and regulatory narratives while overseeing external partners and timelines.

You will contribute to due diligence on collaborations, licences and acquisitions, and interact with leadership on budget, scope and regulatory readiness.

Qualifications

• Expertise in AAV/viral vector CMC including upstream/downstream, formulation and analytics.
• Experience with Phase 3 programs and process validation, PPQ, inspection readiness.
• Proven record managing CDMOs/partners with governance.
• Experience authoring Module 3 content and responding to regulator questions.
• Experience budgeting and cost-of-goods reviews.
• Ability to lead sole sponsor-side CMC across third-party delivery.
• Degree in life sciences or related field.
• Experience with neurological or intraparenchymal delivery programs.
• Exposure to AI methods in process development.

Responsibilities

• Set and govern the CMC development plan through process validation, PPQ and regulatory milestones.
• Oversee partner work and ensure timely, within-scope deliverables.
• Manage clinical supply planning, batch scheduling and release timing.
• Lead due diligence on partnerships, licensing and acquisitions.
• Represent sponsor in regulatory meetings and inspections.
• Maintain CMC risk registers, budgets and cost controls.

Skills

AAV CMC

Regulatory submissions

CDMO management

Budgeting COgS

AI in manufacturing

Cross-functional leadership

CMC strategy

Education

Life sciences degree

Job description

Cpl Life Sciences is partnering with an innovative stealth-mode biotech to appoint a CMC Lead. You will take sole sponsor-side responsibility for chemistry, manufacturing and controls on the programme, owning the CMC and regulatory narratives while overseeing external partners and timelines.

You will contribute to due diligence on collaborations, licences and acquisitions, and interact with leadership on budget, scope and regulatory readiness.