In this role, you’ll partner across R&D and Manufacturing Science & Technology (MSAT) to deliver high‑quality Extractables & Leachables (E&L) toxicology assessments that meet internal standards and regulatory expectations. You’ll work side‑by‑side with nonclinical safety colleagues, vaccine toxicologists and MSAT experts—learning new tools and approaches while shaping submissions that matter.
Key responsibilities
1. Provide toxicology assessments for Extractables & Leachables supporting Large Molecules, Small Molecules and Vaccines.
2. Perform E&L toxicology assessments aligned with R&D scientific standards and ensure appropriate review and documentation prior to final approval.
3. Use in silico/(Q)SAR tools (e.g., Derek Nexus, Leadscope, Toxtree) and expert knowledge to evaluate chemical structures for genotoxicity, mutagenicity and other endpoints.
4. Locate, interpret and critically review nonclinical toxicology data (e.g., genotoxicity, carcinogenicity, skin sensitisation, systemic toxicology) from internal and external data sources and platforms (e.g., ECHA, ToxPlanet, SciFinder, Symphora).
5. Summarise in silico and nonclinical evidence, highlight the most relevant/robust datasets and calculate permissible daily exposures (PDEs) or acceptable daily intakes (ADIs) to support limit-setting in line with GSK and regulatory expectations.
6. Use cheminformatics and predictive tools (e.g., OECD Toolbox, Helium, Leadscope) to analyse physicochemical and structural properties and to identify surrogate compounds with robust data for read‑across.
7. Maintain up‑to‑date knowledge of relevant regulatory guidelines (e.g., ICH Q3E, ICH Q3C, ICH Q3D, ICH M7) and incorporate these into assessments.
8. Support development or update of internal standards, guidance documents, safety thresholds, processes and training materials related to E&L toxicology strategy.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
9. Degree in toxicology, chemistry, biology, biochemistry, pharmacy or related discipline preferred. Advanced degree (MSc, PhD or equivalent) is beneficial.
10. Experience in pharmaceutical or related industries; hands‑on experience working with toxicology data is preferred.
11. Experience interpreting nonclinical toxicology data and familiarity with regulatory guidance relevant to E&L.
12. Practical experience with (Q)SAR/predictive tools and cheminformatics is beneficial.
Skills & competencies
13. Strong technical writing and data‑summary skills (clear, concise toxicology reports).
14. Attention to detail and high standards for accuracy and documentation.
15. Solid quantitative/mathematical competence for exposure and PDE/ADI calculations.
16. Effective collaboration and ability to work across multi‑disciplinary teams.
17. Ability to prioritise, work at pace and manage workload for fixed-term deliverables.
Closing date for applications: 11th March 2026
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.