CMC Leader (Director)

CMC Leader (Director)

We develop, manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we develop and manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

To lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (either small molecule or oligonucleotide) from Commit to Phase 2 (C2P2), through the development of the Phase 3 (P3)/commercial process, the file, review and launch and the completion of the major clinical and CMC/Supply Chain (SC) lifecycle work. The role holder: i) engages with the medicine 6 to 12 months prior to C2P2; ii) takes accountability from the early CMC Leader at C2P2; iii) leads delivery of the P3/commercial process, clinical supplies and files; iv) leads the project through the successful execution of the Product Performance Qualification (PPQ), establishing continuous process verification (CPV) and PAI readiness; v) supports the global file, review, and launch readiness; vi) supports or delivers the further lifecycle P3 studies and CMC/SC sub-projects; and then vii) transitions to the GSC Strategy Lead and the further lifecycle, and supports the completion of any lifecycle projects specified by the lifecycle plan.

Responsibilities

• Accountable for the seamless transition and knowledge transfer from the pre-C2P2 period, through to P2 and P3/commercial process development. The role holder will engage with early CMC Medicine Development CMC Leader and team ~6 to 12mths prior to C2P2 to prepare plans, resources (external and internal spends budgets for the C2P2 recommendations (noting that the timing may be earlier than C2P2 for complex, accelerated medicines)

• Helps define the medicine development strategy and the medicine commercial vision through the Medicine Development Leader (MDL) and Medicine Development Team (MDT) MDL/MDT; define the drug substance (DS), drug product (DP) device, analytical, manufacturing, supply chain, quality, and CMC regulatory approaches through the CMC matrix team. Generate options and recommendations for P3 development & supply, and global regulatory filings that balance time, costs, resources, and risk. Ensure requirements these are captured in the medicine CMC/SC master strategy & plan and securing timely decisions on them through governance.

• Deliver the strategy & plan through the CMC matrix team, including DS, DP, device, analytical, manufacturing, supply chain, Quality Assurance (QA), regulatory, data, statistics, and project management, and in turn through the R&D, GSC and external contract development and manufacturing network, to the agreed timings, resources, and risk mitigation strategies. Manage integration, alignment and performance proactively, anticipating and addressing issues and risks, and securing Specialist Sign Off (SSO) and Subject Matter Expert (SME) inputs, as necessary throughout product development

• The role holder continually monitors for scope changes or threshold breaches in terms of the agreed timing, costs, resources and/or risks (and in relation to the agreed lifecycle sub-project strategy, plan & warranty contract considerations), and engages with senior leaders and/or governance as necessary, to resolve these proactively

• During P3, generate options and recommendations for Product Performance Qualification (PPQ), PAI readiness, global commercial file and launch, and that balance time, resources (EPE & IPE), and risk. Ensure these are captured in the medicine CMC/SC master strategy & plan and develop the Transition of Accountability (ToA) contract with the GSC Strategy Lead. Secure timely decisions on milestone progression through governance.

• During P3 and prior to file/launch, identify post-launch medicine development and commercial needs through the MDL/MDT and the MSCL and the MCL/MCT. Define the DS, DP, device, analytical, manufacturing, supply chain, quality, and CMC regulatory approaches for lifecycle plans. Generate options and recommendations that balance time, costs, resources and risk. Ensuring plans are captured in the further medicine CMC/SC master strategy & ToA contract (including all of the lifecycle P3 and CMC/SC sub-projects and responsibilities). Secure timely decisions on plans through governance.

• Provide the voice of the physical product to the MDL/MDT & Development, and through the MSCL to the MCL/MCT & Commercial, and the corresponding voice of the project to the CMC/SC matrix team, the CMC modalities & GSC

• After completing the transfer of accountability (ToA) contract commitments, seamlessly transfer knowledge and plans to the GSC Strategy Lead, and then, as applicable, lead any follow on development activities, including support for specific marketing files, further P3 trials and specific development targets (e.g., paediatric sub-projects), and represent these to the ongoing MDL/MDT and in support of the MSCL and Medicine Commercial Leader / Team (MCL/MCT)

Qualifications/Skills

Basic Qualifications:

• Extensive experience of pharmaceuticals, CMC and Supply Chain

• The role requires an understanding of CMC disciplines related to the delivery of a large, produced product.

• Area of specialisation in Chemistry, Life Sciences or Bio/chemical engineering.

• Project leadership experience, specifically leadership of multi-disciplinary matrix teams and preferably in a biopharmaceutical product development environment with global teams.

• Broad and deep understanding of how medicines are developed and brought to market.

• Demonstrated delivery of a product through the technology transfer process in some capacity.

• Significant experience of late phase CMC/supply chain development and commercialisation.

• Knowledge of global biopharmaceutical pharmaceutical CMC regulatory requirements.

Preferred Qualifications:

• Advanced degree, PhD, MBA, or equivalent experience in a relevant scientific, technical, or business discipline.

• Broad experience across multiple medicine modalities, such as small molecules, oligonucleotides, biologics, or other advanced therapeutic platforms.

• Experience supporting global product development, regulatory submissions, launch planning, or commercial supply readiness.

• Track record of leading through complexity, managing uncertainty, and enabling high-quality decision-making across senior stakeholder groups.

• Experience operating at the interface of R&D, Supply Chain, Technical, Quality, Regulatory, and Commercial teams.

• Strong external awareness of CMC trends, regulatory expectations, and pharmaceutical development best practice.

Work Location:

This role can be based at Stevenage (UK), Ware (UK) or Upper Providence (USA) and offers a hybrid working model, combining on-site and remote work.