Senior Director-Molecule Steward Lead

GSK

1d•Hybrid

About The Position

The Sr Director - Molecule Steward Lead will lead a group (5-15) of Molecule Stewards who have end to end technical accountability for a portfolio of innovative programs, including Drug Substance, Drug Product, inspection, assembly, packing and related support activities, providing strategic Technical leadership to ensure successful new product introduction, launch, and improvements across the lifecycle (e.g. quality, robustness and productivity). The Senior Director-Molecule Steward Lead will drive program alignment across a portfolio of assets from Commit to Commercial Design through Product sunset. The team will responsibility for representing MSAT in a variety of product lifecycle milestones including, but not limited to: development of the Product Control Strategy, Technology Transfer, PPQ and ongoing maintenance of the Control Strategy to ensure the product is maintained in the desired state of control and meets both Quality and Business objectives. The Molecule Steward (Sr Director) is responsible for developing and delivering the technical elements of the GSC strategy for long-acting injectable products with the GSC Strategic Lead. The Sr Director- Molecule Steward Lead will be the recognized 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 highest levels of quality and robustness.

Requirements

Bachelors degree in life sciences, pharmaceutical sciences, biochemical engineering, or a related field.
Experience in biopharmaceutical development, or a related scientific area.
Experience supporting molecule program management across preclinical and/or clinical stages.
Experience working within cross‑functional, matrixed development teams.
Experience working within external regulatory frameworks (e.g., FDA, EMA, MHRA, PMDA) in a pharmaceutical or biologics development environment.
Experience supporting technology transfer activities within a product development environment.

Nice To Haves

PHD or Masters degree is preferred
Strong communication skills in English and experience presenting technical information to diverse audiences.
Experience using risk-based approaches and project management tools.
Knowledge of global regulatory pathways for clinical development.
Comfort working in matrixed and cross-cultural teams.

Responsibilities

Manage a group of Molecule Stewards (5-10) accountable for end to end technical leadership of various pipeline and in-line programs.
Recruit and develop a world class team.
Serve on Molecule Steward leadership team to drive and improve portfolio and organizational excellence.
Responsible for defining and owning the technical strategy through a product’s lifecycle including (non-exhaustive list): product transfers R&D to GSK sites/ External manufacturing sites & Site to Site (both GSK sites and external manufacturing sites), Product Performance Qualification and Ongoing Continuous Process Verification, leading 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.
Accountable for developing and delivering the Technical Lifecycle Plan (TLP) including major geographical expansion requiring additional CMC activities on top of wave 1, new technologies and second generation programs impacting the manufacturing process, analytical process, pack, device, and associated specifications.
Ensures that product history and knowledge from development through the product’s lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the Global Supply Chain network.
Molecule steward is contributing as key inputter for process history file (PHF) reviewer and approver (if applicable).
Providing technical leadership and subject matter expertise where required for multi-site investigations and/or critical deviations, troubleshooting, and major change programmes across supply nodes.
Stays current and maintains solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices.
Responsible for co-ordinating the technical review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SME’s and sites (if required).
Representing MSAT, providing an MSAT single point accountable decision maker for GSC strategic team, CMC team, for established and new products, ensuring that a product control strategy is defined and maintained to drive a robust product that meets manufacturability criteria.
Must develop and manage strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D and maintain and develop technical talent through mentoring across network; with effective and clear communication on highly technical topics.
Must be able to manage stakeholders effectively.
Demonstrated knowledge of risk management approaches.