Senior Manager, CMC Operations

Company: Scancell Ltd

Responsible To: Head of CMC

Location: Hybrid

Summary of Post

The Senior Manager, CMC Operations will provide senior operational leadership across CMC activities supporting the development of biologics, spanning early- to late-phase development and commercialisation readiness. The role will support and deputise for the Head of CMC as required, providing effective oversight and coordination of CMC activities across process and formulation development, analytical development and testing, process and analytical validation, technical transfers, manufacturing, and supply activities.

The post holder will lead and manage multiple concurrent CMC projects and activities, effectively prioritising competing demands and resources to ensure delivery within ambitious timelines and to the required quality, regulatory, and budgetary standards. They will proactively identify and address technical, operational, and programme challenges, anticipate and manage risks, and implement appropriate mitigation and contingency strategies. They will apply strong scientific and technical judgement to develop practical, scientifically justified, and regulatory-compliant solutions.

The post holder will provide leadership for CMC Operations and have significant responsibility for the management and performance of external CMC vendors. They will build positive, transparent, and collaborative relationships with CDMOs, CROs, and specialist vendors, establishing clear expectations, monitoring performance, constructively challenging where appropriate, and ensuring effective delivery against agreed milestones and programme objectives.

The role will require close collaboration with internal functional leads, including Quality Assurance, Regulatory Affairs, Clinical Operations, and other relevant stakeholders, to ensure effective cross-functional planning, communication, and decision-making. The post holder will contribute to and, where appropriate, lead the preparation, authorship, and review of technical CMC documentation, ensuring that documentation is scientifically robust, accurate, and aligned with regulatory expectations.

Overall, the Senior Manager, CMC Operations will combine strong CMC technical expertise with operational, project, risk, people, and vendor management capabilities to drive the timely, compliant, and high-quality delivery of CMC activities and support the organisation’s biologics development programmes through to commercialisation.

Key Duties and Responsibilities

• Provide senior operational leadership and day-to-day oversight of CMC activities supporting biologics development programmes from pre-clinical development through to commercialisation.
• Lead and manage multiple concurrent CMC projects and activities, prioritising resources, timelines, risks and dependencies to ensure delivery against ambitious programme milestones.
• Support the Head of CMC in the effective operational execution of the CMC strategy and development plans, ensuring alignment with programme objectives and commercialisation requirements.
• Maintain oversight of CMC programme plans, milestones, critical path activities and deliverables, proactively identifying and addressing issues that may impact successful delivery.
• Monitor CMC expenditure against departmental budgets and support effective financial management, including review and triage of vendor invoices.
• Provide operational oversight across the CMC development lifecycle, including formulation development, process development, analytical development and testing, technical transfers, manufacturing, validation, stability and clinical supply activities.
• Lead the operational execution of process development, optimisation and scale-up activities, supporting manufacturing readiness for Phase 3 and commercial supply.
• Provide oversight of analytical method development, qualification, validation and lifecycle management, ensuring analytical activities support programme requirements and regulatory expectations.
• Coordinate technical transfers and manufacturing activities across internal and external partners, ensuring effective planning, execution and delivery against agreed timelines and quality standards.
• Coordinate manufacturing campaigns, batch release, stability programmes and clinical supply activities, ensuring appropriate planning and coordination across CMC, Quality, Regulatory, Clinical Operations and external partners.
• Provide oversight of process characterisation and process validation activities, including Process Performance Qualification (PPQ).
• Maintain oversight of product and process lifecycle management activities, including process improvements, formulation optimisation, comparability assessments and change control.
• Review manufacturing documentation, technical reports, analytical documentation and batch release documentation, ensuring appropriate quality, accuracy and compliance.
• Oversee the investigation and timely resolution of non-conformances and deviations, working closely with relevant technical and Quality functions to ensure robust root-cause analysis, appropriate impact assessment, and effective corrective and preventive actions.
• Support the preparation and review of CMC documentation for Quality Assurance and Regulatory Affairs, ensuring content is accurate, scientifically robust, and aligned with regulatory requirements.