Senior Manager, CMC Operations

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

Post Title: 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.

Qualifications

• Degree in a relevant scientific discipline, such as Pharmaceutical Sciences, Biochemistry, Biotechnology, Biological Sciences, or a related subject.
• Significant CMC experience within the biopharmaceutical/biologics industry, covering development and manufacturing activities from pre-clinical through to late-stage development and commercial readiness.
• Substantial experience in CMC operations and programme/project management, with a demonstrated ability to manage multiple concurrent activities and deliver against ambitious timelines.
• Strong experience managing external CMC partners, including CDMOs, CROs and specialist vendors, with proven ability to establish effective partnerships, manage performance, resolve issues and hold vendors accountable for delivery.
• Broad technical understanding of the development of novel biological products (e.g., DNA, mRNA, recombinant proteins, antibodies, and cell-based therapies), encompassing formulation and process development, analytical development, technology transfer, manufacturing, and process validation.
• Strong understanding of CMC regulatory requirements and experience contributing to or reviewing CMC documentation for regulatory submissions and interactions.
• Experience of technical documentation, including the ability to author, review and provide technical input into CMC reports and regulatory documentation.
• Demonstrated experience in risk management and problem-solving, with the ability to identify and proactively address technical and operational challenges and develop scientifically justified, regulatory-compliant solutions.
• Experience working effectively in cross-functional teams, including close collaboration with Quality Assurance, Regulatory Affairs, Clinical Operations and other business functions.
• Previous people management and leadership experience, including the ability to lead, coach and develop team members.
• Experience working in a lean, matrixed or fast-paced biotech environment, with the ability to manage changing priorities and competing demands.
• Excellent communication and stakeholder management skills, with the confidence to influence internal stakeholders and external partners and to represent CMC at senior-level meetings.
• Knowledge of process characterisation, process validation and PPQ, including scale-up and technology transfer to commercial manufacturing sites.
• Familiarity with analytical method qualification, validation, comparability and lifecycle management, including stability strategies and product specifications.
• Understanding of CMC regulatory submissions and regulatory agency interactions, including INDs, IMPDs, CTAs and BLA/MAA preparation.
• Exposure to regulatory inspections, audits and inspection readiness from a CMC perspective.
• Experience managing global CDMO, CRO and specialist vendor networks, including governance and performance management.
• Knowledge of clinical and commercial supply activities, including manufacturing planning, batch release, stability, packaging and distribution.
• Experience working within a lean, growing or virtual biotech environment, with the ability to operate effectively in a matrix structure.
• Demonstrated ability to develop and improve biologic CMC processes, governance frameworks and ways of working within a growing organisation.
• Exposure to working across international development programmes and geographically dispersed teams and external partners.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to changing business needs.

Further details about Scancell may be found at: www.scancell.co.uk .

Salary: Competitive salary and comprehensive employee benefits