Immunogenicity & Bioanalytical Scientist for mRNA Assays

1000scholars; Oxford; On-site; GBP 45,000 - 75,000; Full time

Job summary

Moderna seeks a Scientist in Immunogenicity, Bioanalytical and Molecular Assays at its Harwell site in Oxford, UK. You will design and deliver immunogenicity and bioanalytical strategies to support clinical development and accelerate mRNA therapeutics from discovery into the clinic.

You will lead ADA/nAb and PK/PD assay development, ensure qualification/validation, and collaborate across research, bioanalysis and clinical operations to translate findings into pipeline opportunities.

Qualifications

• PhD with at least 3 years or MSc with 5+ years in bioanalytical method development, validation and sample analysis.
• Strong knowledge of GCP requirements and regulatory expectations in bioanalytical science.
• Experience with bioanalytical platforms including ECL, immunoassays and cell culture-based assays.

Responsibilities

• Design and execute phase-appropriate bioanalytical strategies supporting regulated clinical programmes.
• Lead the development of immunogenicity assays, including ADA and neutralising antibody (nAb) assays, plus PK/PD assays for therapeutic protein quantitation.
• Ensure bioanalytical assays are developed, qualified and validated per programme timelines and regulatory expectations.
• Develop and optimise assays using ELISA, MSD, cell culture, immunoblotting and related technologies.
• Help establish and expand Moderna's internal bioanalytical capabilities for the growing mRNA portfolio.
• Procure, qualify and maintain analytical laboratory equipment while preparing and updating SOPs.
• Determine, qualify and control critical assay reagents for robust assay performance.
• Collaborate with Preclinical, Clinical Operations and Sample Management to define sample journeys and lab manuals.
• Troubleshoot scientific and technical issues during assay development and regulated activities.
• Communicate findings and objectives effectively within a global matrixed environment.
• Contribute to translating clinical findings into future opportunities across Moderna's pipeline.

Skills

Bioanalytical method development

Assay validation

ELISA / ECL

Regulatory knowledge (FDA/MHRA)

Communication skills

Education

PhD + 3+ yrs

MSc + 5+ yrs

Tools

LIMS

eLNB (ELN)

Job description

Moderna seeks a Scientist in Immunogenicity, Bioanalytical and Molecular Assays at its Harwell site in Oxford, UK. You will design and deliver immunogenicity and bioanalytical strategies to support clinical development and accelerate mRNA therapeutics from discovery into the clinic.

You will lead ADA/nAb and PK/PD assay development, ensure qualification/validation, and collaborate across research, bioanalysis and clinical operations to translate findings into pipeline opportunities.