(Fixed Term) Scientist, Immunogenicity, Bioanalytical and Molecular Assays
On-siteOxford, England, United Kingdom
Job Summary
Design and execute phase-appropriate bioanalytical strategies supporting regulated clinical programmes, including developing and validating immunogenicity, pharmacokinetic, and pharmacodynamic assays using ELISA, MSD, and cell culture technologies. Lead assay development and qualification while establishing internal bioanalytical capabilities to support the mRNA portfolio, ensuring compliance with Good Clinical Practice and global regulatory standards. Troubleshoot technical issues during assay development and partner with multidisciplinary teams to define sample journeys and maintain laboratory equipment and standard operating procedures.
Required Qualifications
- PhD with at least three years of relevant experience
- MSc with five or more years of hands-on experience in bioanalytical method development, validation and sample analysis
- Strong knowledge of Good Clinical Practice (GCP) requirements
- 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
- Experience working with RNA therapeutics, biologics and/or cell therapies
- Working knowledge of translational science and the evolving competitive landscape within the mRNA field
- Excellent attention to detail
- Ability to manage multiple projects within a fast-paced research environment
- 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
- Full-time presence at Moderna's Harwell site
- Enhanced pre-employment check
Desired Qualifications
- Equivalent combinations of education, technical training and relevant laboratory experience
- Experience using Laboratory Information Management Systems (LIMS) and electronic laboratory notebook (eLNB) platforms
- Curiosity, adaptability and a willingness to learn new scientific concepts while challenging conventional thinking
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