GSK
biopharma
MoleculeSteward
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Molecule Steward at GSK. Skills: End-to-End technical accountability for a given product, Strategic technical leadership, Product Control Strategy development and maintenance, Global Supply Chain strategy technical elements, Deep technical expertise, Product Technical Lifecycle Teams leadership. Take end-to-end technical accountability for a given product, from bulk API manufacturing, formulation, packing and related support activities. Provide strategic technical leadership to ensure successful”
Industry & Context.
Excellent problem solver; technical issues are resolved in a timely manner; troubleshooting
What They're Looking For.
Must Have
University Degree (minimum) in Chemistry, Chemical engineering, Pharmaceutical Sciences or similar area, Extensive years’ 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, Experienced in technology transfer, with an understanding of the product development process, Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management, Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management, including supporting process investigations.
Nice to Have
Project management and prioritization skills gained within a complex matrix, Excellent problem solver and ability to think and work creatively, technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and suppliers, Experience managing external partners/CDMO’s in NPI and/or commercial supply, Ability to effectively influence stakeholders at all levels
What You'll Do.
Take end-to-end technical accountability for a given product
from bulk API manufacturing
packing and related support activities
Provide strategic technical leadership to ensure successful new product introduction
quality robustness and productivity improvements across the lifecycle
Representing MSAT in the development of the Product Control Strategy
Co-ordinate Drug Substance
Analytical Strategy and Device Leads to maintain the Product Control Strategy
Ensure the product is maintained in the desired state of control throughout product lifecycle
Develop and deliver the technical elements of the Global Supply Chain strategy
Representing MSAT as technical single-point accountable decision maker to CMC Matrix and Medicine Supply Chain teams
Define and maintain a product control strategy to drive a robust product that meets target manufacturability criteria
Define the End-to-End Product Performance Qualification and Ongoing Continuous Verification Strategy for the product
Maintain accountability for the product
from transfer from R&D throughout its lifecycle
Develop and deliver improvement plans impacting the manufacturing process
and associated specifications
Define technology strategy & specific solutions as required to support the overall product or dose form lifecycle
Lead Product Technical Lifecycle Teams
Co-ordinate the review of regulatory submissions and responses to technical questions within MSAT
Provide leadership and subject matter expertise for investigations and/or critical deviations
and major change programmes
Ensure that product history and knowledge from development through lifecycle is maintained and aligns with knowledge management standards
Manage collaborations with technical staff across the Supply Chain sites
How You'll Work.
Team & Collaboration
Representing MSAT in the development of the Product Control Strategy; Co-ordinates Drug Substance, Drug Product, Analytical Strategy and if appropriate Device Leads; Representing MSAT as technical single-point accountable decision maker to CMC Matrix and Medicine Supply Chain teams; Leading Product Technical Lifecycle Teams; Co-ordinating the review of regulatory submissions and responses to technical questions within MSAT; Ensuring review by appropriate SMEs and sites; Managing collaborations with technical staff across the Supply Chain sites, MSAT & R&D; enable cross functional collaboration across sites, supply chain, R&D and suppliers
Communication Scope
technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders; effective and clear communication on highly technical topics
Process & Methodology
Project management and prioritization skills
Full Job Description
# **Molecule Steward** **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. **Position Summary** This 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, providing strategic technical leadership to ensure successful new product introduction, quality robustness and productivity improvements across the lifecycle. The Molecule Steward is aligned to a new asset at Commit to Commercial Development with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward co-ordinates Drug Substance, Drug Product, Analytical Strategy and if appropriate Device Leads to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control throughout product lifecycle. You will be responsible for developing and delivering the technical elements of the Global Supply Chain strategy with the GSC Strategy Lead and will be a recognised GSC expert in the
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