Molecule Steward
Ware, Hertford, Hertfordshire, SG13, England, UK
Listed on 2026-05-21
-
Quality Assurance - QA/QC
Quality Engineering
Molecule Steward
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, helping to positively impact the health of millions worldwide.
Position SummaryThis role is a truly exciting opportunity for an experienced scientific professional to take end‑to‑end technical accountability for a given product, from bulk API manufacturing, formulation, packing and related support activities. The Molecule Steward will provide strategic technical leadership to ensure successful new product introduction, quality robustness and productivity improvements across the lifecycle. The role is aligned to a new asset at Commit to Commercial Development, representing MSAT in the development of the Product Control Strategy.
When the product transfers to GSC accountability, the Molecule Steward will coordinate Drug Substance, Drug Product, Analytical Strategy and, if appropriate, Device Leads to maintain the Product Control Strategy and ensure the product remains in the desired state of control throughout its lifecycle.
- Represent MSAT as the single‑point accountable decision maker to CMC Matrix and Medicine Supply Chain teams, ensuring a product control strategy is defined and maintained to meet target manufacturability criteria.
- Define the End‑to‑End Product Performance Qualification and Ongoing Continuous Verification Strategy, including trending and sampling plans, and ensure alignment across supply nodes.
- Maintain accountability for the product from transfer from R&D through its lifecycle, ensuring improvement plans (including 2nd generation processes) are delivered for manufacturing, analytical, pack, device, and specifications to add value.
- Maintain solid knowledge of complex scientific subject matter, evolving regulatory policies, guidelines and industry best practices, using this knowledge to develop improvement plans.
- From an MSAT perspective, define technology strategy and specific solutions to support the product or dose form lifecycle.
- Lead Product Technical Lifecycle Teams, identifying and mitigating risks and resolving technical issues promptly.
- Coordinate review of regulatory submissions and responses to technical questions within MSAT, ensuring SME and site review.
- Provide leadership and subject‑matter expertise for investigations, critical deviations, troubleshooting and major change programmes.
- Ensure product history and knowledge from development through lifecycle is maintained and aligns with knowledge‑management standards within the GSC network.
- Collaborate strongly with technical staff across Supply Chain sites, MSAT and R&D, communicating clearly on highly technical topics and operating in an environment of high change and uncertainty.
- University Degree (minimum) in Chemistry, Chemical Engineering, Pharmaceutical Sciences or a similar area.
- Extensive experience in pharmaceutical development and/or manufacturing, ideally in small molecule modality.
- Comprehensive knowledge of external regulatory requirements (MHRA, FDA) and internal/external quality and safety requirements.
- Experience in technology transfer and an understanding of the product development process.
- Knowledge of current and emerging Regulatory Strategies (QbD, GMP for the 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
- Demonstrated experience leading the technical aspects of Product Lifecycle Management, including supporting process investigations.
- Project management and prioritization skills gained within a complex matrix.
- Excellent problem‑solver with creative thinking.
- Strong technical acumen and communication skills, able to articulate complex, technical details to stakeholders and enable cross‑functional collaboration across sites, supply chain, R&D and suppliers.
- Experience managing external partners or CDMOs in NPI and/or commercial supply.
- Ability to effectively influence stakeholders at all levels.
This role can be based in Ware, Worthing, Barnard Castle, UK or Upper Merion or Durham, USA and offers a hybrid working model, combining on‑site and remote work.
Closing Date29th May 2026
Equal Opportunity EmployerGSK is an Equal Opportunity Employer. This ensures that all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
#J-18808-LjbffrTo Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search: