Analyst, Quality Control - Chemistry & Stability (12-Month Fixed Term)

Moderna, Inc.; Oxford; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biotech company in Oxford seeks an experienced Quality Control Scientist. The role involves executing analytical chemistry testing and ensuring compliance with GMP regulations in stability testing. Candidates should have a BA/BSc in Chemistry or Biology and at least 5-7 years in a pharmaceutical Quality Control lab. Join us to impact global health initiatives.

Qualifications

• 5-7 years in a Quality Control Laboratory of a Pharmaceutical Company.
• Strong understanding of GxP regulations (GMP, GLP, GCP, GVP).

Responsibilities

• Execute routine analytical chemistry and stability testing.
• Complete all cGMP documentation for analytical work.
• Maintain stability data and perform statistical analyses.

Skills

Analytical Chemistry

HPLC

Compliance with GxP regulations

Statistical Analysis

Education

BA/BSc in Chemistry or Biology

Tools

LIMS (LabVantage)

Job description

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.

Key Responsibilities:

• 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 (LabVantage) 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.

Additional Responsibilities:

• 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.

Requirements:

• BA/BSc in Chemistry or Biology (preferred) or other relevant scientific discipline
• At least 5-7 years in Quality Control Laboratory of a Pharmaceutical Company
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards)

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.