MSAT Molecule Steward

GSK•Upper Providence, PA

4d•€103,500 - €172,500•Hybrid

About The Position

MSAT 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(s), 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 molecule 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 Global Supply Chain (GSC) accountability, the Molecule Steward co-ordinates Drug Substance, Drug Product, Analytical and if appropriate Device technical strategy to ensure the product is maintained in the desired state of control throughout product lifecycle and meets business and scientific objectives. 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 given product or dose form. In addition to strategic technical leadership, the role will be expected to provide deep technical expertise where required to ensure highest levels of quality and robustness.

Requirements

University Degree (minimum) in Life Sciences (e.g. Biology, Chemistry,etc.) 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 Haves

Direct experience with complex pharmaceutical devices and delivery systems; specific experience with inhalation devices highly desired.
Project management and prioritization skills gained within a complex matrix
Excellent problem solver and ability to think and work creatively
Strong communication skills with the ability to articulate complex, technical details to matrixed team at all levels of the organization.
Ability to effectively influence stakeholders at all levels

Responsibilities

Representing MSAT as technical single-point accountable decision maker to CMC Matrix and Medicine Supply Chain teams, ensuring that a product control strategy is defined and maintained to drive a robust product that meets target manufacturability criteria and quality elements.
Responsible for defining the End-to-End Product Performance Qualification and ongoing Continuous Process Verification strategy for the product, including trending and sampling plans and ensuring alignment and consistency across supply nodes.
Maintaining accountability for the product, from transfer from R&D throughout its lifecycle, ensuring robust continuous improvement plans and technical roadmap (including 2nd generation processes) are developed and delivered improving the manufacturing process, analytical process, pack, device, and associated specifications to maximize the value of the asset(s).
Maintaining solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices.
Accountable for defining technology strategy & specific solutions as required to support the overall product or dose form lifecycle.
Responsible for leading Product Technical Lifecycle Teams (PTLT), ensuring risks are identified and mitigated whilst driving continuous improvement of the technical aspects of the molecule and associated processes.
Responsible for co-ordinating the review of regulatory submissions and responses to technical questions within MSAT.
Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major change programmes.
Driving matrixed leadership to ensure technical issues are resolved in a timely manner.
Ensuring that product history and knowledge from development through lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the GSC network.
Managing strong collaborations across the Supply Chain sites, MSAT & R&D, with effective and clear communication on highly technical topics to all levels of the organization.
Must be able to lead and operate in an environment with high degree of change and uncertainty.