CMC Operations Lead, Biologics Development

Scancell; Oxford; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Scancell Ltd in the United Kingdom is seeking a Senior Manager, CMC Operations to provide senior operational leadership across CMC activities for biologics development from pre-clinical to commercial readiness. You will oversee multiple projects, manage external partners, and ensure timely, compliant delivery of processes, analytics, validation, and manufacturing tasks.

You will collaborate with QA, Regulatory Affairs and Clinical Operations to align strategy with regulatory expectations and

Qualifications

• Degree in a relevant scientific discipline (e.g., Pharmaceutical Sciences, Biochemistry, Biotechnology, Biological Sciences).
• Significant CMC experience from pre-clinical through to late-stage development and commercial readiness.
• Experience managing external CMC partners (CDMOs, CROs) and governance.
• Strong understanding of CMC regulatory requirements and ability to contribute to regulatory submissions.

Responsibilities

• Provide senior operational leadership and day-to-day oversight of CMC activities supporting biologics development programmes from pre-clinical through to commercialisation.
• Lead and manage multiple CMC projects, prioritising resources, timelines and dependencies to meet milestones.
• Support the Head of CMC in the operational execution of CMC strategy and development plans.
• Maintain oversight of CMC programme plans, milestones and critical path activities.
• Monitor CMC expenditure and support financial management, including vendor invoices review.
• Coordinate process development, analytical development and manufacturing activities across internal and external partners.
• Lead scale-up activities and manufacturing readiness for Phase 3 and commercial supply.
• Oversee regulatory documentation input and lifecycle management for CMC.

Skills

CMC operations

Project management

Cross-functional leadership

Regulatory awareness

Vendor management

Biologics development

Risk management

Technical reporting

Education

Degree in a relevant scientific discipline

Job description

Scancell Ltd in the United Kingdom is seeking a Senior Manager, CMC Operations to provide senior operational leadership across CMC activities for biologics development from pre-clinical to commercial readiness. You will oversee multiple projects, manage external partners, and ensure timely, compliant delivery of processes, analytics, validation, and manufacturing tasks.

You will collaborate with QA, Regulatory Affairs and Clinical Operations to align strategy with regulatory expectations and