Lead Immunogenicity & Bioanalytical Scientist, mRNA

Moderna Therapeutics; Oxford; Hybrid; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Healthcare benefits

Paid time off

Harwell site

Job summary

Moderna is strengthening its Harwell site and expanding bioanalytical capabilities to support our growing mRNA pipeline. As a Scientist in Bioanalytical and Molecular Assays, you will design and deliver immunogenicity and bioanalytical strategies to advance clinical programmes, working closely with multidisciplinary teams across research, bioanalysis and clinical development.

You will lead development of assays (ADA, nAb, PK/PD) and ensure qualification/validation to regulatory timelines, using

Qualifications

• 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.
• Strong knowledge of Good Clinical Practice (GCP) requirements and regulatory expectations in bioanalytical science.
• Expert knowledge of bioanalytical assay platforms including electrochemiluminescence (ECL), immunoassays, cell culture-based assays and related clinical assay methodologies.

Responsibilities

• Design and execute phase-appropriate bioanalytical strategies supporting regulated clinical programmes.
• Lead development of immunogenicity assays (ADA and nAb) and PK/PD assays for therapeutic protein quantitation.
• Ensure bioanalytical assays are developed, qualified and validated in line with 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 to support the growing mRNA portfolio.
• Procure, qualify and maintain analytical laboratory equipment and SOPs.

Skills

PhD + 3+ years

MSc + 5+ years

GCP knowledge

Bioanalytical platforms

RNA therapeutics familiarity

Cell culture experience

Regulatory awareness

Education

PhD in bioanalytical science

MSc in related field

Tools

ELISA

MSD platform

LIMS

ELN/eLNB platforms

Job description

Moderna is strengthening its Harwell site and expanding bioanalytical capabilities to support our growing mRNA pipeline. As a Scientist in Bioanalytical and Molecular Assays, you will design and deliver immunogenicity and bioanalytical strategies to advance clinical programmes, working closely with multidisciplinary teams across research, bioanalysis and clinical development.

You will lead development of assays (ADA, nAb, PK/PD) and ensure qualification/validation to regulatory timelines, using