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.
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..,):
1. 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.
2. 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
3. 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.
4. 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.
5. 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
6. Support sites by providing leadership and expertise for analytical aspects in the frame of complex investigations related to the accountable product.
7. 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).
About You:
This role would suit a highly motivated person who has strong experience working in a cross-functional, global supply organisation with first-class stakeholder management and a track record of delivery. As a subject-matter expert you will be degree-qualified with excellent scientific knowledge. The role requires strong relevant knowledge (eg; small molecule) and experience in order to manage comparability studies and other key activities (to support product life cycle). You must also have demonstrably strong people skills, be resilient and calm under pressure, have a strong continuous improvement mindset, and a proven ability to drive performance.
CLOSING DATE for applications: Friday 5th of September 2025 (COB).
Basic Qualifications / Experience:
8. Relevant experience and qualifications (eg; BS in a scientific discipline -pharmacy, chemistry, biology, biochemistry, or related technical discipline).
9. Strong understanding of drug substance and drug product dose forms manufacturing disciplines and relationship with analytical testing and control strategy.
10. Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.)
Preferred Qualifications / Experience:
11. Knowledge and understanding of the statistics related to CPV, test method equivalence assessment, specification setting, stability studies evaluations, between others.
12. Knowledge of product lifecycle key aspects: technical risk assessment (TRA), product performance qualification (PPQ) and continued process verification (CPV).
Benefits:
GSK offers a range of benefits to its employees, which include, but are not limited to:
13. Competitive base Salary
14. Annual bonus based on company performance
15. Opportunities to partake in on the job training courses
16. Opportunities to attend and partake in industry conferences
17. Opportunities for support for professional development
18. Access to healthcare and wellbeing programmes
19. Employee recognition programmes
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage .
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.