Principal Scientist, Bioanalytical & Molecular Assays

Job title: Principal Scientist, Bioanalytical & Molecular Assays

About the Role Based at Moderna’s Harwell site, the Principal Scientist 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. The role intersects molecular biology, bioanalysis, genomics, informatics, and clinical development, and includes opportunities to leverage digital and data-driven approaches, including Generative AI-enabled tools.

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 development and implementation of RT-qPCR, dPCR, and NGS-based assays across applications (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 programs.

What We're Looking For

• PhD in a relevant field (e.g., molecular biology, biochemistry, genomics) with extensive experience in molecular assay development and validation.
• Proven track record leading hands-on design and execution of RT-qPCR, dPCR, and NGS-based assays across diverse clinical applications.
• Experience with end-to-end assay development lifecycle, including method development, qualification/validation, QC/QA, and technology transfer.
• Strong ability to write and review technical documentation (validation plans, reports, SOPs) and ensure regulatory alignment (GCLP).
• Experience with clinical sample testing and managing data quality and operational workflows; familiarity with CAPA and inspection readiness.
• Collaborative, cross-functional leadership with ability to work independently and drive programs forward.

Nice to Have

• Exposure to advanced analytics and Generative AI-enabled tools to accelerate discovery and operational excellence.