Overview
The Role: Joining Moderna offers the opportunity to contribute to a pioneering team revolutionizing medicine through mRNA technology. This position supports Moderna’s Harwell-based quality control (QC) activities, focusing on GMP-compliant stability and analytical chemistry testing, and global stability programs. The role involves operating analytical instrumentation, managing cGMP documentation, and delivering timely results within the QC chemistry function. The role may involve exposure to Generative AI tools and digital platforms enhancing Moderna's QC infrastructure.
This position, reporting to the Associate Director, Quality Control, is part of the Harwell QC team supporting stability and analytical testing and ensuring alignment with regulatory requirements.
What You’ll Do
- 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.
- 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.
Key Mindsets
- We obsess over learning. We don’t have to be the smartest—we have to learn the fastest. In a highly technical and regulated environment, your ability to absorb evolving regulatory guidance, apply new analytical tools, and learn from experimental data is critical.
- We digitize everywhere possible using the power of code to maximize impact on patients. With Generative AI tools and digital systems like LIMS, comfort with digital platforms and data-driven execution will enhance speed, accuracy, and compliance.
Qualifications
- Education: BA/BSc in Chemistry or Biology (preferred) or other relevant scientific discipline
- Experience: 5–7 years in a Quality Control Laboratory of a Pharmaceutical Company
- Demonstrated aptitude to learn GxP regulations (GMP, GLP, GCP, GVP or other applicable standards)
- Site-based role requiring full-time presence at Moderna's site; not eligible for remote work.
- Enhanced pre-employment check may be required per Moderna policy.
Benefits and Culture
At Moderna, we offer quality healthcare and insurance benefits, lifestyle spending accounts, fitness and wellness programs, family planning benefits, generous paid time off, and location-specific perks. Benefits may vary by country and employment type.
About Moderna: Since 2010, Moderna has pursued an leading mRNA technology platform and onshore vaccine production initiatives. We value an in-person culture with a 70/30 in-office model to foster innovation, teamwork, and mentorship. We are committed to equal opportunity and a diverse, inclusive workplace, and provide accommodations as needed during the hiring process.
To learn more about current opportunities, visit modernatx.com/careers.
Equal Opportunity
Moderna is an equal opportunity employer. We do not discriminate on any protected characteristic and will provide reasonable accommodations to qualified applicants requesting them during the hiring process.