(Fixed Term) Analyst, Quality Control, Microbiology

Moderna

85d

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. In this essential role, you will serve as the Microbiology Quality Control Analyst at our Harwell facility, directly supporting GMP manufacturing operations. Reporting to the Associate Director of Quality Control, you will carry out routine environmental and critical utility monitoring while performing key microbiological testing across raw materials, excipients, and drug substances for mRNA products. You’ll collaborate cross-functionally on method transfers, validations, and contribute to laboratory systems aligned with current Good Manufacturing Practices (cGMP). With the opportunity to operate at the interface of digital systems and biotechnological innovation, this position offers access to tools and data environments closely tied to Generative AI platforms supporting Quality Operations across Moderna globally.

Requirements

• BSc in a relevant scientific discipline with 5 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 prioritise and complete multiple projects and tasks in a fast-paced environment.
• Proven ability to conduct investigations.

Responsibilities

• Conducting routine environmental monitoring (EM) and sampling of critical utilities such as water systems in a GMP manufacturing facility.
• Executing microbiological analyses including TOC, Conductivity, Bioburden, Endotoxin, Sterility, and other GMP QC methods.
• Supporting GMP testing for product release, stability, and validation samples.
• Preparing, shipping, and receiving contract laboratory samples, including those for microbiological identification.
• Participating in new microbiological method transfers in collaboration with Analytical Sciences & Technology (AS&T) teams.
• Supporting development, implementation, and maintenance of laboratory systems in line with cGMP expectations.
• Performing general laboratory support activities including reagent preparation, equipment maintenance, and housekeeping.
• Participating in audit readiness activities, including support to internal and external audit teams.
• Assisting in equipment and method qualifications, and potentially troubleshooting assay methods and instrumentation.
• Drafting and revising SOPs, protocols, reports, and contributing to quality system documentation (e.g., deviations, CAPAs, EM excursions, and change controls).
• Applying Good Documentation Practices and ensuring full compliance with GxP and Data Integrity requirements.
• Completing all assigned training per schedule and requalification timelines.
• Supporting junior team members as required with data review, troubleshooting, and training.

Benefits

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments
• Location-specific perks and extras!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees