Analyst, Quality Control, Microbiology

Analyst, Quality Control, Microbiology

Moderna

Oxford, United Kingdom

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.

Here’s What You’ll Do:

Your key responsibilities will be:

• 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.

Your responsibilities will also include:

• 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.

Here’s What You’ll Bring to the Table:

• 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.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.