Principal Scientist, Bioanalytical & Molecular Assays

Principal Scientist, Bioanalytical & Molecular Assays

Moderna

Oxford, United Kingdom

The Role:

This role is based at Moderna’s Harwell site and offers the opportunity to shape the future of molecular and genomic biomarker strategies across a diverse clinical portfolio. Working at the intersection of molecular biology, bioanalysis, genomics, informatics, and clinical development, you will play a critical role in advancing programs from discovery through clinical development while helping translate clinical insights into future pipeline opportunities.

As a senior individual contributor within the Molecular Assays team, you will provide scientific and technical leadership for the development, validation, and deployment of advanced molecular assays that generate high-quality clinical data to support decision-making across multiple therapeutic programs. You will operate with significant independence, partnering across functions to deliver innovative assay solutions while leveraging emerging digital and data-driven approaches, including opportunities to engage with advanced analytics and Generative AI-enabled tools that accelerate scientific discovery and operational excellence.

Here's What You'll Do:

• Provide hands-on scientific leadership and laboratory support for the design, development, optimization, and delivery of fit-for-purpose molecular assays supporting clinical endpoints;
• Lead the development and implementation of RT-qPCR, dPCR, and NGS-based assays across a broad range of applications, including gene expression, viral load analysis, mRNA pharmacokinetics, bulk RNA sequencing, targeted RNA sequencing, single-cell RNA sequencing, TCR/BCR repertoire profiling, targeted DNA panels, and pathogen or viral sequencing;
• Own end-to-end assay lifecycle activities, including method development, qualification, validation, and technology transfer to internal laboratories and external CRO partners;
• Author and review validation plans, reports, protocols, acceptance criteria, and supporting technical documentation in accordance with GCLP requirements and industry best practices;
• Ensure assays are scientifically robust, reproducible, scalable, and aligned with clinical program objectives and regulatory expectations;
• Oversee phase-appropriate clinical sample testing activities, ensuring rigorous quality control, quality assurance, data integrity, and operational excellence throughout assay execution;
• Lead deviation investigations, CAPA activities, and inspection-readiness efforts to support compliance and audit preparedness;
• Serve as a scientific subject matter expert for molecular assay strategies across multiple clinical development programs spanning Phase 1 through Phase 3;
• Work independently while providing matrix leadership across multidisciplinary teams of molecular biologists, NGS scientists, and bioinformaticians;
• Mentor colleagues and contribute to the continued development of scientific capabilities across the organization;
• Partner closely with Clinical Development, Biomarkers and Translational Medicine, Bioanalytics, Regulatory Affairs, Quality Assurance, and Data and IT teams to ensure alignment between assay strategies and broader program goals;
• Integrate basic science research, bioanalytical approaches, genomics, and informatics to support clinical development decisions and generate actionable biological insights;
• Reverse-engineer clinical findings to identify novel scientific opportunities that can inform and strengthen Moderna’s future pipeline;
• Effectively communicate scientific strategies, project plans, risks, challenges, and study outcomes to both technical and non-technical stakeholders;
• Influence cross-functional decision-making by translating complex molecular and genomic data into clear, actionable recommendations;
• Contribute to the adoption of innovative technologies, advanced computational approaches, and AI-enabled solutions that enhance assay development, data interpretation, and translational research capabilities;
• Thrive within a fast-moving, highly collaborative environment where scientific rigor, innovation, and patient impact remain central to every decision.

The key Moderna Mindsets you’ll need to succeed in the role:

• We obsess over learning. We don’t have to be the smartest we have to learn the fastest;
• We act with dynamic range, driving strategy and execution at the same time at every step.

Here’s What You’ll Need (Basic Qualifications):

Education

• Ph.D. in Molecular Biology, Genomics, or related field with 9+ years of biotech/pharma experience (or M.S. with 12+ years of directly relevant experience).

Technical Expertise

• Deep, hands‑on experience developing and validating clinical qPCR, dPCR, NGS assays and managing end‑to‑end workflows from method development, validation, sample testing and reporting;
• Strong knowledge of GCLP/GLP guidelines preferred and requirements for phase‑appropriate validation for clinical trial biomarker/endpoints; familiarity with GxP/MHRA/GCLP/ICH expectations and inspection readiness;
• Proficiency with library prep (amplicon, hybrid capture, poly(A)/RNA workflows), nucleic acid extraction from diverse matrices, and orthogonal QC (Bioanalyzer/Tapestation, qPCR/dPCR);
• Demonstrated track record building and validating bioinformatics pipelines;
• Experience integrating genomics data and instrumentation with LIMS/ELN, data governance, and secure handling of clinical data strongly desired.