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MCmodernatx.com logo

modernatx.com

GBR - OX - MITC - Harwell, United Kingdom

Analyst, Quality Control, Chemistry & Stability.

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 readiness: Perform essential laboratory support activities, including reagent preparation, sample management, routine equipment maintenance, laboratory housekeeping, and the ordering, stocking, and management of QC consumables and supplies. Help maintain a safe, organised, and inspection-ready laboratory environment. Support analytical troubleshooting and technical development: Assist with investigations into analytical assay performance, method-related issues, and laboratory equipment problems. Share technical knowledge with colleagues and support more junior laboratory staff through data review, training, and troubleshooting activities. Contribute to quality investigations and continuous improvement: Participate in the preparation and execution of quality system records, including investigations, deviations, change controls, and Corrective and Preventive Actions (CAPAs). Author and revise SOPs, technical protocols, and reports while identifying opportunities to improve laboratory workflows, analytical reliability, and stability program execution. Uphold GMP compliance and data integrity: Execute laboratory and stability activities in accordance with applicable GxP regulations, internal policies, SOPs, and work instructions. Apply Good Documentation Practices and data integrity principles to ensure analytical results, electronic records, and supporting documentation are accurate, complete, traceable, and readily available for regulatory audits and inspections. Explore digital innovation in analytical quality control: Contribute to opportunities to enhance stability data management, analytical trending, scientific knowledge sharing, and laboratory efficiency through digital tools, advanced analytics, and appropriately approved Generative AI-enabled technologies, while maintaining strict GxP compliance and data integrity requirements. Maintain training and technical competency: Complete all assigned training within defined timelines, including required requalification activities. Continuously strengthen technical knowledge of analytical methods, laboratory systems, regulatory expectations, and evolving scientific practices. Foster collaboration and scientific excellence: Work collaboratively across Quality Control, Manufacturing, Quality Assurance, Regulatory Affairs, and external testing partners to support effective analytical testing and stability program delivery. Promote a positive, inclusive culture that values scientific curiosity, innovation, accountability, and continuous improvement. Contribute to special projects and broader QC priorities: Support additional scientific, analytical, quality, or stability-related projects as assigned, bringing technical expertise, flexibility, and a proactive approach to delivering results. 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.” “We behave like owners. The solutions we’re building go beyond any job description.” Here’s What You’ll Need (Basic Qualifications) Education: BA/BSc in Chemistry (preferred) or other relevant scientific discipline Experience: 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) As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check. Our Working Model As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home
Pay
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GBR - OX - MITC - Harwell, United Kingdom
Work
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Type
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Posted
21 Oct, 2026
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