Scientific Leader - Extractables and Leachables (E&L)

Extractables and Leachables (E&L) - Scientific Expert

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

An exciting opportunity for an expert in the field of Extractables and Leachables (E&L) to join a trace analysis team in an industry leading pharmaceutical company.

The successful candidate will join a team that utilises state-of-the-art LC-MS and GC-MS instrumentation to provide key information for projects at all stages of pharmaceutical development. In this position, the successful candidate will primarily undertake risk assessment and mitigation of extractable and leachables in pharmaceutical manufacturing processes as well as leading collaboration across the GSK network, on behalf of R&D, to align on E&L control strategy. The successful candidate will work with a high level of autonomy to lead E&L analytical projects and develop capability within the laboratory environment as well as contributing to regulatory submissions and overseeing completion of work packages placed at CROs.

Key Responsibilities:

• Project management and contribution to regulatory submissions

• Extensively risk assess the relevant GSK portfolio to ensure patient safety from potential extractables and leachables.

• Contribute to internal and external consortia to align with regulatory guidance and internal strategy on E&L

• Provide support/training to more junior members of the team, particularly with respect to the risk assessment process and laboratory-based experimentation

• Be active in supporting the development of methodology to detect E&L (Extractables and leachable) compounds using LC-MS (liquid chromatography–mass spectrometry) or (gas chromatography–mass spectrometry) GC-MS

Basic Qualifications:

• Bachelor of Science or PhD in Chemistry or related field

• Experience in risk assessment and risk mitigation with regards to extractables and leachables essential.

• Experience managing structured communications strategically to ensure alignment on project requirements and timelines.

• Experience in independently handling high-quality data and reports

• Experience in analytical chemistry, predominantly in the analysis of trace levels of compounds.

• Experience in liaising with CMO’s and CRO’s

Work Arrangements:

This role offers hybrid working (3 days per week minimum onsite). Working mode across the Stevenage and Ware R&D sites.

PLEASE NOTE:

This role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Ware. The location of this role will therefore subsequently change to Ware in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

Closing Date for Applications: 16/08/2026

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Skills

Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Automation Technology, Bioprocessing, Chemical Processes, Data Analysis Tools, Dosage Forms, Drug Development, Matrix Leadership, Method Development, Technical Problem-Solving

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.

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