Analyst, Quality Control, Microbiology
Moderna Updated 9 October 2026
PharmaBiotechRegulatory AffairsQuality Assurancegmpfdacroinform
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. Based at our Harwell, Oxfordshire site, you will join Quality Control as an individual contributor, reporting to the Manager, Microbiology. You will perform routine environmental monitoring (EM) and water sampling across the GMP manufacturing facility while supporting microbiological testing of GMP QC raw materials, excipients, drug substances, and drug product intermediates for mRNA products manufactured at Moderna and affiliated contract organizations. This is a hands-on laboratory role spanning environmental and critical utility monitoring, microbiological testing, method transfers, qualifications and quality systems. You will work within a highly regulated cGMP environment, applying Good Documentation Practices and Data Integrity requirements while supporting release, stability and verification/validation activities. You will also have opportunities to contribute to Moderna’s digitally enabled way of working and gain exposure to emerging technologies, including Generative AI tools, where appropriate within our controlled and compliant quality environment. Here's What You'll Do: Perform routine environmental monitoring and critical utility sampling activities across the GMP manufacturing facility. Conduct analysis of water samples, including TOC, Conductivity, Bioburden and Endotoxin. Execute GMP QC Microbiology methods, with a focus on Sterility testing, Bioburden analysis, Endotoxin and other methodologies as required. Support testing for release, stability, method and verification/validation samples. Collaborate with AS&T groups on new method transfers and participate in method transfer projects involving internal and external testing laboratories. Contribute to the development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements. Support audit teams during internal and vendor audits. Prepare, ship and receive contract laboratory testing samples, including samples intended for microbiological identification. Perform general laboratory support activities, including reagent preparation, equipment maintenance and housekeeping. Participate, as required, in equipment and method qualifications, validations and method transfers. Perform data entry using Good Documentation Practices. Assist with troubleshooting assay methods and equipment, while supporting more junior colleagues with data review, training and troubleshooting. Participate in authoring quality system records, including EM excursions, investigations, deviations, change controls and CAPAs, and write or revise SOPs, protocols and reports. Foster a positive and inclusive working culture that promotes collaboration, innovation and continuous improvement. Follow all relevant GxP regulations, guidelines and company policies to maintain compliance with regulatory and internal requirements. Execute activities precisely as defined within internal guiding documents, including SOPs and work instructions. Follow Good Documentation Practices and Data Integrity requirements, ensuring data, documentation and records are complete, appropriately maintained and available to support audits and inspections. Complete training within the assigned learning plan according to defined timelines and prescribed requalification cadence. Contribute to projects assigned within QC Microbiology while maintaining the technical rigor required of a GMP-regulated laboratory. Here's What You'll Need: BSc in a relevant scientific discipline with a minimum of 2 years of Quality Control experience in a cGMP organization, with a focus on Microbiology. Hands-on experience with a range of microbiological testing techniques and analyses, such as Vitek, Isolator Technology, Bioburden, BET and Sterility testing. Working knowledge of relevant and current FDA, EU and ICH guidelines and regulations is preferred. Working experience within a GMP environment. Ability to collaborate effectively within a dynamic, cross-functional matrix environment. Ability to prioritize efficiently and complete multiple projects and tasks within a fast-paced environment. Proven ability to conduct investigations. As part of Moderna’s commitment to workplace safety, this position may require an enhanced pre-employment check. 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 Bring to the Table: BSc in a relevant scientific discipline with a minimum of 2 years Quality Control experience in a cGMP organization with a focus on Microbiology. Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others) Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. Working experience in a GMP environment. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. Proven ability to conduct investigations. As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check. This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. 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 e
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