V&V Senior Scientist / Principal Scientist
Core
Lead verification and validation activities for a first-in-class in vitro diagnostics platform, focusing on assay integration, study execution, and regulatory support.
Role type
Senior/Principal Scientist (Assay R&D)
Builds
In vitro diagnostic assays and platforms for women's health
Domain
Healthcare diagnostics / Bioengineering
Required skills
assay integration, study planning, protocol development, statistical analysis, risk assessment, design of experiments, regulatory documentation, nucleic acid assays, biosensors, microarrays
Preferred skills
GLP/GxP principles, design control, quality systems
Technologies
nucleic acid assays, biosensors, microarrays
Responsibilities
Lead analytical verification and validation activities including study planning, protocol development, execution, analysis, and technical reporting. Translate product requirements into verification strategies and acceptance criteria. Identify and resolve assay and process performance issues. Apply statistical methods and risk assessment tools to evaluate performance.
Seniority
Senior, hands-on IC