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Nanopath is developing a first-in-class in vitro diagnostics platform to transform disease diagnosis. The company aims to replace lengthy molecular testing workflows by delivering rapid, high-quality diagnostics closer to the patient, with a focus on women's health and underserved populations. Headquartered at The Engine in Kendall Square, Nanopath is committed to health equity and corporate sustainability.
The Senior Scientist / Principal Scientist will lead verification and validation (V&V) activities for Nanopath's diagnostic platform within the Assay R&D team. This is a highly hands-on role focused on assay integration, requiring both strategic planning and direct experimental execution.
Key responsibilities include:
- Leading analytical verification and validation activities, including study planning, protocol development, execution, analysis, and technical reporting
- Translating product requirements into V&V strategies, study designs, acceptance criteria, and risk-based testing approaches
- Identifying, investigating, and resolving assay and process performance issues, including unexpected results and failure modes
- Applying statistical methods, design of experiments, and risk assessment tools to evaluate performance and support data-driven decisions
- Partnering with Engineering, Quality, and Regulatory teams to ensure studies and documentation support design control and regulatory submissions
The role combines technical depth in assay development with regulatory and quality systems knowledge, requiring someone who can bridge R&D execution with compliance requirements.
QUALIFICATIONS:
- PhD or Master's degree in bioengineering, biomedical engineering, molecular biology, chemistry, or related field with 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 documentation practices for regulated diagnostics
- Experience with nucleic acid assays, biosensors, and/or microarrays
- Excellent organizational skills, attention to detail, and efficiency in task completion
- Strong communication and presentation abilities
- Experience in cross-functional and collaborative work environments
- Passion for Nanopath's mission in women's health diagnostics
