Scientist, Immunogenicity, Bioanalytical and Molecular Assays

Moderna

Oxford, United Kingdom

As a Scientist within the Bioanalytical and Molecular Assays team, you will play a pivotal role in advancing Moderna's clinical development programmes by designing and delivering innovative immunogenicity and bioanalytical strategies. Working closely with multidisciplinary teams across research, bioanalysis and clinical development, you will help generate the high-quality data that accelerates novel mRNA-derived therapeutics from discovery into the clinic while contributing to future pipeline innovation.

Here's What You'll Do:

Design and execute phase-appropriate bioanalytical strategies supporting regulated clinical programmes;
Lead the development of immunogenicity assays, including anti-drug antibody (ADA) and neutralising antibody (nAb) assays, alongside pharmacokinetic (PK) and pharmacodynamic (PD) assays for therapeutic protein quantitation;
Ensure bioanalytical assays are developed, qualified and validated in line with programme timelines and applicable regulatory expectations;
Develop and optimise assays using ELISA, MSD, cell culture, immunoblotting and other relevant bioanalytical technologies;
Help establish and expand Moderna's internal bioanalytical capabilities to support the growing mRNA portfolio;
Procure, qualify and maintain analytical laboratory equipment while preparing and maintaining Standard Operating Procedures (SOPs);
Determine, qualify and control critical assay reagents to support robust and reproducible assay performance;
Partner closely with Preclinical, Clinical Operations and Sample Management teams to define sample journeys and develop laboratory manuals supporting regulated studies;
Troubleshoot scientific and technical issues that arise during assay development and regulated bioanalytical activities;
Communicate scientific concepts, experimental findings, programme objectives and data analyses effectively within a highly matrixed global environment;
Contribute to the integration of basic science research, bioanalysis and informatics to advance programmes into clinical development while helping translate clinical findings into future opportunities across Moderna's pipeline.

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

PhD with at least three years of relevant experience, or an MSc with five or more years of hands-on experience in bioanalytical method development, validation and sample analysis. Equivalent combinations of education, technical training and relevant laboratory experience will also be considered;
Strong knowledge of Good Clinical Practice (GCP) requirements together with an understanding of current regulatory expectations and industry trends within bioanalytical science;
Expert knowledge of bioanalytical assay platforms including electrochemiluminescence (ECL), immunoassays, cell culture-based assays and related clinical assay methodologies;
Hands-on experience with cell culture assays is advantageous;
Experience working with RNA therapeutics, biologics and/or cell therapies is preferred;
Working knowledge of translational science and the evolving competitive landscape within the mRNA field;
Curiosity, adaptability and a willingness to learn new scientific concepts while challenging conventional thinking;
Excellent attention to detail and the ability to manage multiple projects within a fast-paced research environment;
Experience using Laboratory Information Management Systems (LIMS) and electronic laboratory notebook (eLNB) platforms is preferred;
Knowledge of FDA, MHRA and global regulatory data standards;
Excellent communication skills with the ability to explain scientific concepts, programme objectives and data analyses across multidisciplinary teams;
This is a site-based position requiring full-time presence at Moderna's Harwell site and is not eligible for remote working;
As part of Moderna's commitment to workplace safety, this role may require an enhanced pre-employment check.