Small Molecule CMC Leader - Senior Director

GSK•Upper Providence, PA

12d•Hybrid

About The Position

You will lead CMC (Chemistry, Manufacturing and Controls) for a Medicines Development and Innovation programme. You will lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (either small molecule, biopharm or CGT) 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 & CMC/SC lifecycle work. The role holder: i) engages with the medicine 6 to 12mths 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) ensures the successful execution of the process performance qualification (PPQ), establishing continuous process verification (CPV) and pre-approval inspection readiness; v) ensures the global file, review, and launch readiness; vi) delivers the further lifecycle P3 studies and CMC/SC sub-projects; and then vii) transitions to the MSCL and the further lifecycle, and supports the completion of any lifecycle projects specified by the lifecycle plan. The Sr. Director role leads projects with CMC budgets in the >£30M range and/or peak year sales in excess of £500M. The role is complemented with a director role which leads projects with CMC budgets in the < £30M range and/or peak year sales < £500M.

Requirements

BsC or PhD in Life sciences, (bio)chemical engineering, pharmaceutical sciences or relevant area
Significant experience of pharmaceuticals, CMC & SC
Experience at the director or preferably senior director level for ca.
Experience of developing, presenting, and defending P2, P3 & lifecycle CMC/SC strategies, plans and resources to governance
Experience working with, and influencing, very senior leaders internally and externally through decision making, changes, issues, and risk management: this should include US, EU, Japan & China health authorities and in both the marketing review and pre-approval inspection settings
Leadership of international, multi-disciplinary P2, P3 & lifecycle CMC/SC teams; this should include external collaborators and CDMOs; this should include experience of successfully leading medicines through P3, file, launch and early lifecycle
Experience developing people as a mentor, coach, teacher and either a matrix and/or line leader
Proven success leading cross-functional teams in a matrix environment.
Breadth and depth of experience of P2, P3 & lifecycle CMC and supply chain aspects, of the development, manufacture, commercial filing, review and approval and clinical and commercial supply of small molecule, biopharm or CGT medicines and the associated regulatory & quality standards; this should include device development & marketing requirements, US, EU, China & Japan development, marketing & launch requirements, lifecycle CMC/SC changes & commercial compliance & quality standard-
Strong hands-on experience in CMC through late-stage development for small molecules, biologics or advanced modalities.
Practical experience with tech transfer, process scale-up and external manufacturing.
Experience authoring or contributing to CMC sections of regulatory submissions.
Clear decision-making, problem solving and communication skills for technical and non-technical audiences.

Responsibilities

Accountable for the seamless transition and knowledge transfer from the pre-C2P2 period and eMDCL, through to P2 and P3/commercial process development.
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/SC 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 (CMC board, Development Review Board & Portfolio Investment Board).
Deliver the strategy & plan through the CMC/SC 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.
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 (CMC board, DRB and/or PIB), 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 ToA contract with the MSCL.
Secure timely decisions on milestone progression through governance (CMC board, DRB & PIB).
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 (CMC board, DRB & PIB).
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 Medicine Supply Chain Leader (MSCL), 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).
May additionally: line manage MDI Directors; lead collaboration interfaces; lead CMC/SC due diligence reviews; and/or lead systems and process updates.