Molecule Steward; Senior Director), Long-Acting Injectables

Molecule Steward (Senior Director), Long-Acting Injectables

Business Introduction We 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 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.

The Molecule Steward (Sr Director) is the single point of end‑to‑end technical accountability for a portfolio of long‑acting injectable products, including drug substance, drug product, inspection, assembly, packing and related support activities. The role provides strategic technical leadership to ensure successful new product introduction and improvements across the lifecycle (e.g., quality, robustness and productivity). The Molecule Steward is aligned to a new asset at Commit to Commercial Design with responsibility for representing MSAT in the development of the Product Control Strategy.

When the product transfers to GSC accountability, the Molecule Steward coordinates Drug Substance, Drug Product, Analytical Strategy and Device Lead to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control throughout its lifecycle. The Molecule Steward will be the recognised expert in long‑acting injectable products and, in addition to strategic technical leadership, the role will be expected to provide deep technical expertise where required to ensure the highest levels of quality and robustness.

• Define and own the technical strategy through a product's lifecycle, including product transfers from R&D to GSK sites or external manufacturing sites, Site to Site, Product Performance Qualification and Ongoing Continuous Process Verification, leading the Product Technical Lifecycle Team (PTLT) and yearly Manufacturing Robustness Review Board meetings (MRRB) to ensure risks are identified, escalated, mitigated and resolved, ensuring alignment and consistency across supply nodes.
• Develop and deliver the Technical Lifecycle Plan (TLCP) including major geographical expansion requiring additional CMC activities, new technologies and second‑generation programs that impact the manufacturing process, analytical process, pack, device and associated specifications.
• Maintain product history and knowledge from development through the product's lifecycle and align it with knowledge management standards for the product or dose form within the GSC network; contribute as a key inputter for the Process History File (PHF) reviewer and approver where applicable.
• Provide technical leadership and subject‑matter expertise for multi‑site investigations and/or critical deviations, troubleshooting and major change programmes across supply nodes.
• Stay current on complex scientific subject matter, evolving regulatory policies and guidelines, and industry best practices.
• Co‑ordinate the technical review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SMEs and sites where required.
• Represent MSAT and serve as the MSAT single point accountable decision maker for the GSC strategic team and CMC team for established and new products, ensuring a product control strategy is defined and maintained to drive a robust product that meets manufacturability criteria.
• Develop and manage strong collaborations with technical staff across Supply Chain sites, MSAT & R&D and mentor technical talent across the network with effective and clear communication on highly technical…