CMC Leader (Director)

About the role

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.

Responsibilities

• Engages with the medicine 6 to 12 months 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)
• Generates options and recommendations for P3 development & supply, and global regulatory filings that balance time, costs, resources, and risk
• Ensures requirements are captured in the medicine CMC/SC master strategy & plan and secure timely decisions on them through governance
• Delivers 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
• Manages 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
• During P3, generates options and recommendations for Product Performance Qualification (PPQ), PAI readiness, global commercial file and launch, and balances time, resources (EPE & IPE), and risk
• Ensures these are captured in the medicine CMC/SC master strategy & plan and develops the Transition of Accountability (ToA) contract with the GSC Strategy Lead
• Secures timely decisions on milestone progression through governance
• During P3 and prior to file/launch, identifies post-launch medicine development and commercial needs through the MDL/MDT and the MSCL and the MCL/MCT
• Generates options and recommendations that balance time, costs, resources and risk
• Ensures 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)
• Secures timely decisions on plans through governance
• Provides 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
• Transitions to the GSC Strategy Lead and the further lifecycle, and supports the completion of any lifecycle projects specified by the lifecycle plan
• Supports the completion of any lifecycle projects specified by the lifecycle plan

Qualifications/Skills

• Extensive experience of pharmaceuticals, CMC and Supply Chain
• 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

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.