Quality Control - Stability & Analytical Chemistry | Harwell, Oxfordshire | 12-Month Contract | Full-Time Onsite | Up to £22.00 per hour, depending on experience.
Join a leading pharmaceutical team establishing a new facility in Harwell focused on mRNA therapeutics. You'll support vaccine production for respiratory diseases, work with advanced analytical tools and digital platforms, and collaborate with experts across academia, the NHS, and government.
Key Responsibilities:
1. Perform analytical chemistry and stability testing using HPLC, UPLC, GC, UV, Karl Fischer, DLS, and other techniques.
2. Support testing of raw materials, components, in-process samples, and drug substances.
3. Complete cGMP documentation for all analytical work in compliance with regulatory standards.
4. Enter data into LIMS (LabVantage) and complete electronic assay forms for traceability.
5. Conduct HPLC (AEX) and NaOH plate-reader assays for manufacturing stat testing.
6. Prepare reagents, manage inventory, maintain equipment, and ensure lab housekeeping.
7. Ensure safe laboratory operations and contribute to EHS compliance.
8. Manage procurement and stock of lab consumables and supplies.
Stability Program Duties:
9. Execute stability operations including set down, pull, labelling, verification, inventory updates, and disposal.
10. Author, review, and revise stability protocols, SOPs, and technical reports.
11. Maintain and trend stability data, perform statistical analyses, and ensure real-time study visibility.
12. Coordinate sample shipment and testing data with external labs.
13. Update internal databases and binders with stability information.
14. Support regulatory submissions and ensure alignment with FDA, EU, and ICH guidelines.
Additional Responsibilities:
15. Troubleshoot analytical methods and instrumentation as needed.
16. Train and mentor junior staff.
17. Contribute to investigations, deviations, CAPAs, and change controls.
18. Promote a positive, inclusive, and collaborative team culture.
19. Ensure adherence to GDP, data integrity, and internal SOPs.
20. Complete all required training and qualifications per assigned learning plans.
Candidate Requirements:
21. BA/BSc in Chemistry, Biology, or a related scientific discipline.
22. 5-7 years of experience in a pharmaceutical Quality Control laboratory.
23. Strong understanding of GxP regulations (GMP, GLP, GCP, etc.).
24. Comfortable working with digital platforms, LIMS systems, and data-driven workflows.
25. Must be available to work full-time onsite at the Harwell facility.
26. May be subject to enhanced pre-employment background checks.
Ideal Mindset:
27. Eager to learn and adapt quickly in a highly technical and regulated environment.
28. Digitally fluent and enthusiastic about using code and automation to improve outcomes.
29. Collaborative and committed to fostering a positive team culture.
Should you require any support or assistance, please contact your local Gi Group office.
Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Gold status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.