Analyst, Quality Control - Chemistry & Stability

Position: Analyst, Quality Control - Chemistry & Stability (12-Month Fixed Term)
The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

Moderna's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all.

This position, reporting to the Associate Director, Quality Control, is an essential part of the Harwell QC team focused on GMP-compliant stability and analytical chemistry testing. As a key contributor, you will support critical release and stability testing operations and play a major role in the management of global stability programs. You will operate and maintain a suite of sophisticated instrumentation, manage cGMP documentation, and support the timely delivery of results across the QC chemistry function.

The role offers direct involvement with cutting-edge analytical techniques, stability data management, and regulatory compliance frameworks - as well as exposure to Generative AI tools and digital platforms enhancing Moderna's QC infrastructure. Here's What You'll Do:
Your key responsibilities will be:
Execute routine analytical chemistry and stability testing using HPLC, UPLC, GC, UV, Karl Fischer, particle size analysis (DLS), and other analytical techniques. Support testing across raw materials, components, in-process and drug substance samples. Complete all cGMP documentation for analytical work in full compliance with applicable guidelines. Perform LIMS (Lab Vantage) data entry and complete electronic assay forms for traceability and review.

Carry out HPLC (AEX) and NaOH plate-reader assays in support of manufacturing stat testing. Provide general laboratory support: reagent preparation, inventory management, equipment maintenance, and housekeeping. Ensure safe laboratory operations, actively contributing to EHS compliance. Participate in procurement and stock management of lab consumables and supplies. Your responsibilities will also include:
Conduct stability program operations: set down, pull, labeling, verification, inventory updates, and disposal. Author, review, and revise stability protocols, SOPs, and technical reports. Maintain and trend stability data, performing statistical analyses and ensuring real-time visibility of study progress. Interface with external labs for sample shipment and testing data coordination, and update internal databases and binders accordingly. Support regulatory submissions by contributing to stability sections and ensuring alignment with FDA, EU, and ICH guidelines.

Assist with troubleshooting analytical methods and instrumentation as required. Support training and mentorship of junior staff as needed. Contribute to quality systems documentation including investigations, deviations, CAPAs, and change controls. Promote a positive, inclusive, and collaborative culture in line with Moderna's values. Ensure strict adherence to GDP, data integrity, and internal SOPs across all executed tasks. Complete all required training and qualifications in accordance with assigned learning plans.

The key Moderna Mindsets you'll need to succeed in the role:
We obsess over learning. We don't have to be the smartest-we have to learn the fastest. In this highly technical and regulated environment, your ability to absorb evolving regulatory guidance, apply new analytical tools, and quickly learn from experimental data will be critical to your effectiveness. We digitize everywhere possible using the power of code to maximize our impact on patients.

With increasing use of Generative AI tools and digital systems like LIMS at the core of Moderna's QC infrastructure, your comfort with digital platforms and data-driven execution will allow you to unlock greater speed, accuracy, and compliance. Here's What You'll Need:
Requires BS in a relevant science or engineering discipline plus 5 years' experience in a biotechnology manufacturing/quality/development environment; or an MS with 2-5 years' experience; or 10+ years professional experience with 5 years' being in a biotechnology manufacturing/quality/development environment. This position is site-based, requiring you to be at Moderna's site…