Principal Scientist, Bioanalytical & Molecular Assays

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

This role is based at Modernas 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.

Heres What Youll 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 Modernas 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 youll need to succeed in the role:

• We obsess over learning. We dont 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.

Heres What Youll 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 handson experience developing and validating clinical qPCR dPCR NGS assays and managing endtoend 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…