Principal Scientist, Bioanalytical & Molecular Assays

Overview

Join Moderna at the Harwell site to lead development of advanced molecular assays that support clinical endpoints across multiple programs. You will work across molecular biology, bioanalysis, genomics, informatics, and clinical development to translate findings into pipeline opportunities. As a senior contributor, you will guide assay design, validation, and deployment, leveraging data-driven approaches and AI-enabled tools to accelerate discovery and operational excellence. You will collaborate with cross-functional teams to ensure robust, regulatory-aligned assay strategies with meaningful patient impact.

Pay / Benefits

• Best-in-class healthcare
• Fertility, adoption, and surrogacy benefits
• Generous paid time off including vacation, holidays, sabbatical
• Mental health and fitness/well-being resources
• Family-building benefits
• Discretionary year-end shutdown

Responsibilities

• Provide hands-on leadership for design, development, optimization, and delivery of fit-for-purpose molecular assays for clinical endpoints
• Lead development and implementation of RT-qPCR, dPCR, and NGS-based assays across gene expression, viral load, mRNA PK, bulk and single-cell RNA sequencing, TCR/BCR repertoire, DNA panels, and pathogen sequencing
• Own end-to-end assay lifecycle: method development, qualification/validation, and tech transfer to internal labs and CROs
• Author and review validation plans, reports, protocols, acceptance criteria, and supporting docs per GCLP and industry best practices
• Ensure assays are robust, reproducible, scalable, and aligned with clinical objectives and regulatory expectations
• Oversee phase-appropriate clinical sample testing, QA/QC, data integrity, and operational excellence
• Lead deviation investigations, CAPA activities, and inspection-readiness for compliance
• Serve as scientific SME for molecular assay strategies across Phase 1–3 programs
• Work independently while providing matrix leadership to molecular biologists, NGS scientists, and bioinformaticians
• Mentor colleagues and contribute to developing scientific capabilities across the organization
• Partner with Clinical Development, Biomarkers, Bioanalytics, Regulatory Affairs, QA, and Data/IT to align assay strategies with program goals
• Integrate basic science, bioanalysis, genomics, and informatics to support decisions and generate insights
• Reverse-engineer clinical findings to identify novel opportunities for the pipeline
• Communicate strategies, plans, risks, and outcomes to technical and non-technical stakeholders
• Influence cross-functional decisions by translating complex data into actionable recommendations
• Contribute to adopting innovative technologies and AI-enabled solutions to enhance assay development and translational research
• thrive in a fast-moving, collaborative environment where scientific rigor and patient impact drive decisions

Key requirements

• Ph.D. in Molecular Biology, Genomics, or related field with 9+ years biotech/pharma experience (or M.S. with 12+ years)
• Hands-on experience developing/validating clinical qPCR, dPCR, and NGS assays across end-to-end workflows
• Strong knowledge of GCLP/GLP; familiarity with GxP/MHRA/GCLP/ICH expectations and inspection readiness
• Proficiency in library prep (amplicon, hybrid capture, poly(A)/RNA), nucleic acid extraction, and orthogonal QC (Bioanalyzer/Tapestation, qPCR/dPCR)
• Proven track record building/ validating bioinformatics pipelines; experience integrating genomics data with LIMS/ELN and data governance
• Experience handling clinical data securely and enabling data-driven decisions

• Strong communication to both technical and non-technical stakeholders
• Leadership and mentorship across multidisciplinary teams
• Independent, proactive problem-solving and strategic thinking
• RT-qPCR, dPCR, NGS assay development/validation
• Library prep techniques (amplicon, hybrid capture, RNA workflows)
• Nucleic acid extraction from diverse matrices

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