Analyst, Quality Control, Chemistry & Stability

Moderna; Oxford; On-site; GBP 55,000 - 80,000; Full time

Job summary

Moderna is establishing a leading research, development, and manufacturing facility at Harwell to support onshore mRNA vaccine production for respiratory diseases in the UK. At Moderna's Harwell site, you will play a critical role in ensuring the quality, integrity, and stability of materials and products supporting our manufacturing operations.

Reporting to the Associate Director, Quality Control, you will combine hands-on analytical chemistry expertise with coordination of GMP stability

Qualifications

• Experience performing cGMP-quality control testing for materials and products.
• Proficient with HPLC/UPLC, GC, UV, DLS, KF analyses.
• Knowledge of GMP stability protocols and regulatory guidelines.

Responsibilities

• Deliver high-quality analytical chemistry and stability testing for raw materials to product release.
• Support manufacturing process testing with HPLC AEX and plate-reader assays.
• Coordinate GMP stability studies for drug substance and drug product.
• Manage stability samples from labeling to storage and disposal.
• Maintain LIMS data entry, electronic forms, and stability databases.
• Perform data trending and statistical analyses on stability results.

Skills

Analytical chemistry

Stability testing

Data analysis

LIMS experience

Tools

HPLC/UPLC

KF analysis

LIMS

AEX

Job description

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is establishing a leading research, development, and manufacturing facility at Harwell to support onshore mRNA vaccine production for respiratory diseases in the UK.

This long term investment will create skilled jobs and strengthen collaboration with academic, NHS, and government partners. We welcome experts ready to help expand access to life saving vaccines.

At Moderna's Harwell manufacturing facility, you will play a critical role in ensuring the quality, integrity, and stability of materials and products supporting our mRNA manufacturing operations. Reporting to the Associate Director, Quality Control, you will combine hands‑on analytical chemistry expertise with the coordination and execution of GMP stability programs, using advanced analytical technologies, laboratory information systems, and scientific data analysis to support manufacturing, product release, and regulatory compliance. This is an opportunity to contribute to global stability programs, strengthen analytical excellence, and explore emerging digital and Generative AI‑enabled technologies within a highly regulated, science‑driven environment.

Here's What You'll Do:

• Deliver high-quality analytical chemistry and stability testing: Perform routine cGMP Quality Control testing supporting raw materials, components, in-process materials, drug substance, product release, and stability programs. Apply analytical techniques including High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), UV spectroscopy, Dynamic Light Scattering (DLS) for particle analysis, and Karl Fischer (KF) analysis, ensuring accurate, reliable, and scientifically robust results.
• Support critical manufacturing process testing: Perform HPLC Anion Exchange Chromatography (AEX) and NaOH plate reader‑based assays as required to support manufacturing process stat testing. Work closely with manufacturing and Quality Control colleagues to deliver timely analytical results that support operational decision‑making and manufacturing continuity.
• Execute global GMP stability programs: Support the planning, coordination, and execution of GMP stability studies for drug substance and drug product, ensuring activities are conducted in accordance with approved stability protocols, Standard Operating Procedures (SOPs), and applicable GMP, FDA, EU, and International Council for Harmonisation (ICH) guidelines.
• Manage stability samples throughout their lifecycle: Coordinate and perform stability sample set‑down and scheduled pull activities, including sample labelling, quantity verification, inventory updates, and documentation within LIMS and applicable logs. Support stability sample assessment, inventory reconciliation, storage management, and disposal activities in accordance with established procedures.
• Coordinate stability schedules and testing activities: Assist in developing and maintaining GMP stability study schedules, ensuring stability samples are pulled, distributed to testing laboratories, and processed within defined timelines. Collaborate with internal testing teams and external partners to support timely study execution and reporting.
• Maintain accurate laboratory and stability data systems: Use LabVantage Laboratory Information Management System (LIMS) to enter analytical results, execute Electronic Assay Forms, and perform stability‑related transactions, including data entry, review, and approval. Maintain accurate and current stability databases, inventory records, and supporting documentation to ensure complete sample and data traceability.
• Perform scientific data trending and statistical analysis: Analyse stability testing results to identify trends, evaluate product performance over time, and support scientific assessment of stability data. Maintain up‑to‑date stability tables, charts, and statistical analyses across ongoing studies, contributing to data‑driven quality and regulatory decisions.
• Develop stability protocols, technical reports, and regulatory documentation: Create, review, revise, and approve stability protocols and reports within the scope of assigned responsibilities. Contribute to the preparation and review of stability‑related sections for regulatory submissions, ensuring scientific accuracy, data integrity, and alignment with current regulatory requirements.
• Coordinate external laboratory testing and data management: Organise and execute stability sample shipments to external testing laboratories, supporting appropriate sample tracking and documentation. Request, retrieve, and review stability testing data and reports from external vendors and shared repositories, ensuring internal stability binders, databases, and study records remain accurate and complete.
• Maintain laboratory operational r