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 expertise related to all aspects of the late-phase product lifecycle (PhIII/PPQ/Commercial) for key GSK products. The ASTL is accountable for one or more small molecule key GSK products, including the analytical control strategy (ACS) from R&D to commercial launch, managing comparability studies and characterization strategies to support post-approval changes.
Responsibilities:
1. Provide technical expertise for programs, projects, and activities related to the product(s) under ASTL accountability, ensuring business priorities such as NPI, product transfers, post-approval changes, and regulatory submissions are met.
2. Own and maintain the Analytical Control Strategy (ACS), updating it throughout the product lifecycle, recommending specifications, and integrating novel technologies as needed.
3. Manage comparability studies and characterization strategies supporting post-approval changes, and contribute to regulatory protocols and reports.
4. Collaborate across functions to meet asset needs and mitigate risks, working with R&D, GSC, Technical, and Regulatory teams.
5. Ensure knowledge transfer of analytical methods to other GSK and external sites.
6. Evaluate new analytical testing technologies related to the control strategy.
7. Support sites in complex investigations related to the accountable product.
8. Represent ACS during audits and inspections.
This role suits a motivated individual with experience in a global supply organization, strong stakeholder management, and a proven track record in delivering projects. A scientific degree (e.g., pharmacy, chemistry, biology) and relevant experience in small molecules and lifecycle activities are required. Strong people skills, resilience, continuous improvement mindset, and performance management skills are essential.
Qualifications:
* BS in a scientific discipline (pharmacy, chemistry, biology, biochemistry, or related technical field)
* Understanding of drug substance and drug product manufacturing and analytical control strategies
* Experience in regulatory document authoring (IND, IMPD, BLA, MAA)
* Knowledge of statistical methods related to CPV, test method equivalence, specifications, and stability studies
* Familiarity with product lifecycle aspects such as TRA, PPQ, and CPV
About GSK:
GSK is a global biopharma company committed to uniting science, technology, and talent to combat diseases. We aim to improve the health of 2.5 billion people by the end of the decade, focusing on respiratory, immunology, oncology, HIV, and infectious diseases. We foster an inclusive environment where our people can thrive and are committed to equal opportunity employment.
We offer competitive salaries, bonuses, professional development opportunities, healthcare, wellbeing programs, and recognition initiatives. For more, visit our 'Life at GSK' webpage.
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