Senior Scientist R&D
Core
Design and development of molecular assays for IVD & CDx programs, leading validation studies and ensuring regulatory compliance for FDA submissions.
Role type
Senior Scientist, Molecular Assay Development
Builds
In vitro diagnostic (IVD) and companion diagnostic (CDx) molecular assays
Domain
Healthcare / Precision Medicine / Molecular Biology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Nucleic acid technologies, NGS, PCR, qPCR, assay design, validation planning, regulatory compliance (FDA/EUA), project leadership, SOP development
Preferred skills
Cross-functional collaboration, budget tracking, process improvement
Technologies
NGS, PCR, qPCR
Responsibilities
Lead validation team from project inception through launch, design assay performance specifications, troubleshoot technical issues, author validation plans and summaries, ensure activities meet regulatory requirements, manage R&D design documents
Seniority
Senior, hands-on IC
