(Fixed Term) Senior Specialist, Quality Control, Microbiology

Moderna

11d • Onsite

About The Position

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. As a Microbiology Quality Control Analyst, you will play a pivotal role in supporting the development and release of Moderna’s mRNA medicines manufactured at our Harwell facility. Reporting to the Associate Director of Quality Control, you will be responsible for routine environmental and utility monitoring, GMP microbiological testing, and lab operations support in a highly regulated environment. You'll collaborate on method transfers, assist with validations and investigations, and help ensure that all testing meets the highest standards of data integrity and compliance. This role provides a dynamic opportunity to work hands-on with advanced biotechnology platforms while contributing to continuous improvement in lab processes. You'll also gain exposure to generative AI-supported lab systems as Moderna continues digitizing lab operations. This is a critical hands-on role for a technically driven individual contributor passionate about microbiology, compliance, and patient impact.

Requirements

• BA/BS in a scientific discipline.
• Working experience: +5 years (or MS in a relevant scientific discipline with 2 years) with a focus in micro testing.
• Experience with Microbiological methods, including Bioburden, Sterility, BET, Micro sequencing, others for routine testing for cGMP QC raw materials, excipients, drug substance and finished product.
• Working experience in a GMP environment.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
• 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.
• This position is site-based, requiring you to be at Moderna’s site full-time.
• This position is not eligible for remote work.
• As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

Responsibilities

• Perform routine environmental monitoring (EM) and critical utility sampling across the Harwell GMP manufacturing facility.
• Execute microbiological analysis of water samples, including Total Organic Carbon (TOC), Conductivity, Bioburden, and Endotoxin testing.
• Conduct GMP QC microbiological testing including Sterility testing, Bioburden analysis, Endotoxin, and related methodologies.
• Support the analysis of samples for release, stability, method verification, and validation.
• Collaborate with Analytical Sciences & Technology (AS&T) groups on method transfers for internal and external QC laboratories.
• Prepare and manage shipping/receiving of contract lab samples, including those for microbial identification.
• Contribute to audit readiness and support internal and external audit teams.
• Support laboratory operations by preparing reagents, maintaining equipment, and ensuring cleanroom hygiene and documentation.
• Assist with method and equipment qualifications and participate in validation activities.
• Troubleshoot analytical methods and lab instrumentation issues and provide mentorship to junior analysts where required.
• Ensure compliance with GxP regulations and internal SOPs, maintaining complete and accurate documentation aligned with data integrity standards.
• Author and revise SOPs, protocols, technical reports, and contribute to deviation investigations, CAPAs, and change controls.
• Foster a collaborative, inclusive, and improvement-oriented laboratory culture.
• Complete all assigned training within the required timelines and requalification periods.

Benefits

• Best-in-class 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees