Nanopath
V&V Senior Scientist / Principal Scientist
Cambridge, MA +1 · Principal · Full-time · Posted Sep 29, 2026
- Location
- Cambridge, MA
Cambridge, Massachusetts, United States - Experience
- 5+ years of relevant industry experience.
- Education
- PhD or master’s degree in bioengineering, biomedical engineering, molecular biology, chemistry, or a related field.
About the job
Lead hands-on verification and validation of Nanopath’s diagnostic platform, integrating assays and generating evidence and documentation for design control and regulatory submissions.
What you'll do
- Plan, develop protocols for, execute, analyze, and report analytical verification and validation studies.
- Translate product requirements into strategies, study designs, acceptance criteria, and risk-based testing approaches.
- Investigate assay and process performance issues using statistical methods, design of experiments, and risk assessment tools.
What they ask for
- PhD or master’s degree in bioengineering, biomedical engineering, molecular biology, chemistry, or a related field.
- 5+ years of relevant industry experience.
- Experience with verification and validation in a regulated diagnostic product development environment.
- Familiarity with design control, quality systems, GLP/GxP principles, or regulated-diagnostics documentation; experience with nucleic acid assays, biosensors, and/or microarrays.
Tools
GLP/GxP
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