Scientist, IVD BioDevelopment
Core
Develop and validate laboratory tests (assays) for cell-free DNA testing to inform personalized health care decisions, specifically focusing on oncology products.
Role type
Senior IC scientist (IVD BioDevelopment)
Builds
Laboratory tests and assays for oncology diagnostics
Domain
Healthcare / Oncology / Molecular Biology / NGS
Required skills
Molecular biology, Next-Generation Sequencing (NGS) workflows, assay development and validation, experimental design, data analysis (Excel, JMP), regulatory compliance (CLIA, CAP, ISO 13485, ISO 14971), SOP/protocol authoring
Preferred skills
High-throughput NGS workflows, DNA extraction, library preparation, PCR/qPCR/multiplex PCR, IVD/CLIA laboratory testing experience
Technologies
NGS, DNA extraction, PCR, qPCR, multiplex PCR, JMP, Excel
Responsibilities
Plan, execute, analyze, and present data from moderate- to high-complexity experiments; coordinate study design with biostatistics and bioinformatics; characterize analytical performance studies; author and review SOPs, protocols, and transfer documents; train junior team members on SOPs and workflows
Seniority
Mid-to-Senior, hands-on IC