Site Name: UK - Hertfordshire - Ware, UK - County Durham - Barnard Castle
Posted Date: Aug 21 2025
The Analytical and Materials Science Function is a global team supporting GSK’s new product introduction into the market and manufacturing sites with projects aligned to technology transfers, material changes and rapid resolution of RCAs associated with business-critical supply issues.

BASIC QUALIFICATIONS / EXPERIENCE:

• Relevant experience and qualifications (eg; BS in a scientific discipline -pharmacy, chemistry, biology, biochemistry, or related technical discipline).
• Strong understanding of drug substance and drug product dose forms manufacturing disciplines and relationship with analytical testing and control strategy.
• Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.)

PREFERRED QUALIFICATIONS / EXPERIENCE:

• Knowledge and understanding of the statistics related to CPV, test method equivalence assessment, specification setting, stability studies evaluations, between others.
• Knowledge of product lifecycle key aspects: technical risk assessment (TRA), product performance qualification (PPQ) and continued process verification (CPV).

JOB PURPOSE:

The ASTL supports the delivery of business-critical projects with the provision of expertise linked to all aspects of the late-phase of the product lifecycle (PhIII/PPQ/Commercial) for key GSK products. The ASTL is accountable for one or more small molecule key GSK products.
The ASTL has accountability for the analytical control strategy (ACS) - end to end - taking accountability from the R&D team at commercial launch. The role manages and defines appropriate comparability studies and suitable characterization strategies to support post-approval changes.

KEY RESPONSIBILITIES (INCLUDE..,):

• Provide technical expertise for programs, projects and activities related to the specific product/s under the ASTL accountability to ensure business priorities and targets are met eg. NPI, product transfers, post-approval changes, regulatory submissions.
• Own and be accountable for the Analytical control strategy (ACS). Maintain and update the ACS through the post-approval product lifecycle eg. recommending specification strategy, recommending novel technologies based on product needs. Ensure that method developed for NPI are robust with respect to commercial product lifecycle, focusing on the highest risk / most complex methods
• Manage and define comparability studies and suitable characterization strategies to support post-approval changes for the accountable product/s. Provide input and expertise into comparability protocols and summary reports for regulatory changes/documents.
• Partner with teams across the business in a matrix-fashion in order to meet asset needs, and to identify and mitigate risks i.e. with R&D, GSC (site and central), Technical (site and central), Regulatory.
• Ensure that method knowledge is embedded in the onward Technical Transfer to other GSK sites (and to external sites).
• Drive evaluation of new technologies for analytical testing related to the control strategy
• Support sites by providing leadership and expertise for analytical aspects in the frame of complex investigations related to the accountable product.
• Represent ACS for the accountable product/s during audits and inspections.
  Location: The successful applicant can be based at any GSK UK-based site (preferably a manufacturing supply chain site).