Principal Scientist, Bioanalytical & Molecular Assays
Core
Lead the design, development, validation, and deployment of advanced molecular assays (RT-qPCR, dPCR, NGS) to generate high-quality clinical data supporting decision-making across multiple therapeutic programs from discovery through Phase 3 clinical development.
Role type
Principal Scientist, Bioanalytical & Molecular Assays
Builds
Clinical-grade molecular assays and bioinformatics pipelines for mRNA therapeutics
Domain
Biopharma / Molecular Biology / Genomics / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
RT-qPCR, dPCR, NGS assay development and validation, library prep (amplicon, hybrid capture), nucleic acid extraction, bioinformatics pipeline building, GCLP/GLP compliance, method qualification, technology transfer, deviation investigation, CAPA management
Preferred skills
GxP/MHRA/ICH regulatory expectations, LIMS/ELN integration, data governance, advanced analytics, Generative AI tools
Technologies
RT-qPCR, dPCR, NGS, Bioanalyzer, Tapestation, LIMS, ELN
Responsibilities
Design and validate RT-qPCR, dPCR, and NGS-based assays for gene expression, viral load, mRNA pharmacokinetics, and single-cell sequencing; Own end-to-end assay lifecycle including method development, qualification, validation, and transfer to CROs; Author validation plans, protocols, and technical documentation per GCLP; Oversee clinical sample testing ensuring quality control, data integrity, and operational excellence; Lead deviation investigations, CAPA activities, and inspection-readiness efforts; Serve as subject matter expert for molecular assay strategies across Phase 1–3 programs; Mentor colleagues and provide matrix leadership to multidisciplinary teams; Integrate genomics, informatics, and basic science to support clinical decisions; Reverse-engineer clinical findings to identify novel pipeline opportunities; Communicate scientific strategies and data insights to technical and non-technical stakeholders
Seniority
Principal, hands-on IC with strategic influence and mentorship
