Analytical Science & Technology Lead (ASTL) - Small Molecule

GSK•King of Prussia, PA

About The Position

The Analytical Science and Technology Lead (ASTL) is part of GSK’s global Manufacturing Science and Technology (MSAT) Analytical Science Function, which supports new product introductions, manufacturing sites, technology transfers, second-generation processes, and critical investigations with supply impact. The ASTL leads and delivers business-critical projects covering analytical aspects of the late-phase lifecycle for key GSK small-molecule products, and is accountable for several products. The role owns the Analytical Product Strategy (APS) end to end, taking accountability from the R&D Analytical Leader at first-wave approval. It maintains and updates the strategy throughout the post-approval lifecycle, including recommendations on specifications, stability strategies, and analytical technologies. The ASTL manages comparability studies and characterization strategies that support post-approval changes, and provides technical analytical leadership across product programs, projects, and activities. The position works in a global, cross-functional matrix with R&D, Global Supply Chain, Technical, and Regulatory teams. It supports regulatory submissions and health-authority inspections, embeds method knowledge in technology transfers to GSK and external sites, evaluates new technologies including process analytical technology (PAT), and provides analytical expertise for complex root-cause investigations. The successful applicant may be based at GSK’s Ware, UK manufacturing site, or Upper Merion, USA site.

Requirements

Relevant scientific education or qualifications, such as a BS or MS in pharmacy, chemistry, biology, biochemistry, or a related technical discipline.
Experience with analytical method development, validation, and transfer.
Biopharmaceutical industry experience, including relevant experience with late-stage products and Critical Quality Attribute (CQA) assessment.
Strong understanding of drug-substance and drug-product dosage-form manufacturing disciplines and their relationship to analytical testing and control strategy.
Experience authoring regulatory files, such as IND, IMPD, BLA, or MAA submissions.
Strong relevant knowledge, such as small-molecule expertise, and experience supporting new product introduction or complex lifecycle investigations.
Strong leadership, stakeholder-management, and people skills, with a track record of delivery in a cross-functional global supply organization.
Ability to remain resilient and calm under pressure, a continuous-improvement mindset, and a demonstrated ability to drive performance.

Nice To Haves

Knowledge of statistics related to Continued Process Verification (CPV), test-method equivalence assessment, specification setting, and stability-study evaluations.
Knowledge of product-lifecycle topics including technical risk assessment (TRA), product performance qualification (PPQ), and continued process verification (CPV).

Responsibilities

Provide technical analytical leadership for programs, projects, and activities related to accountable products, supporting business priorities and targets such as new product introduction, product transfers, change management, and regulatory submissions.
Own and maintain the Analytical Product Strategy (APS) throughout the post-approval product lifecycle, including recommendations on specifications, stability strategies, and analytical technologies.
Ensure analytical methods developed by R&D are robust for the product lifecycle, with a focus on the highest-risk and most complex methods.
Manage and define comparability studies and suitable characterization strategies to support post-approval changes.
Compile and recommend acceptance criteria for release and stability tests to support comparability strategies involving technology transfer, process scale changes, and material changes.
Provide analytical input and expertise for comparability protocols and reports, incorporating non-routine physical-properties data and Materials Science recommendations for regulatory changes and documents, and ensuring follow-up on submission questions and answers.
Partner with R&D, Global Supply Chain, Technical, and Regulatory teams in a matrix structure to meet asset needs and identify and mitigate risks.
Ensure method knowledge is embedded in subsequent technology transfers to other GSK sites and external sites.
Drive evaluation of new technologies, including PAT, for analytical testing related to the product control strategy.
Support sites with analytical expertise for root-cause analysis during complex investigations concerning accountable products.
Defend the APS for accountable products during health-authority inspections.