Site Name: UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence
Posted Date: Feb 11 2025
As the SeniorDirector, Chemistry Manufacturing and Controls, your role will be to 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 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) 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.
Key Responsibilities:
* Accountable for the seamless transition and knowledge transfer from the pre-C2P2 period and eMDCL, through to P2 and P3/commercial process development. The role holder will engage with early CMC Medicine Development CMC Leader and team ~6 to 12 months prior to C2P2 to prepare plans, resources (external and internal spends budgets for the C2P2 recommendations).
* Helps define the medicine development strategy and the medicine commercial vision through the Medicine Development Leader (MDL) and Medicine Development Team (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.
* 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.
* The role holder continually monitors for scope changes or threshold breaches in terms of the agreed timing, costs, resources and/or risks.
* During P3, generate options and recommendations for Product Performance Qualification (PPQ), PAI readiness, global commercial file and launch.
* 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.
* Provide the voice of the physical product to the MDL/MDT & Development, and through the MSCL to the MCL/MCT & Commercial.
* After completing the transfer of accountability (ToA) contract commitments, seamlessly transfer knowledge and plans to the Medicine Supply Chain Leader (MSCL).
* May additionally: line manage MDI Directors; lead collaboration interfaces; lead CMC/SC due diligence reviews; and/or lead systems and process updates.
Experience Needed:
* Experience of pharmaceuticals, CMC & SC.
* Experience at the director or preferably senior director level for ca. 5 years.
* 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.
* Leadership of international, multi-disciplinary P2, P3 & lifecycle CMC/SC teams.
* Experience developing people as a mentor, coach, teacher and either a matrix and/or line leader.
* Breadth and depth of experience of P2, P3 & lifecycle CMC and supply chain aspects.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
#J-18808-Ljbffr