Senior Operations Manager (Hybrid) in Oxford

Post Title: Senior Manager, CMC Operations Company: Location: Hybrid 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. Lead and manage multiple concurrent CMC projects and activities, prioritising resources, timelines, risks and dependencies to ensure delivery against ambitious programme milestones. · 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). · 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. 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. · 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. · Knowledge of process characterisation, process validation and PPQ, including scale-up and technology transfer to commercial manufacturing sites. · 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. · These job duties/responsibilities may change or vary in response to changing business needs. Salary: Competitive salary and comprehensive employee benefits