V&V Senior Scientist / Principal Scientist

Nanopath • Cambridge, MA

11h

About The Position

Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed. We aim to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient. Our mission is to improve patient outcomes – starting with women – through a purpose-built platform that delivers actionable results within a single office visit.
The company is headquartered at The Engine, the premier tough technology incubator in the Kendall Square ecosystem. We are collectively committed to health equity and the design of solutions for underserved populations and low-resource settings. Corporate sustainability – both environmental and social – is at the forefront of our decision making.
About the Role
Nanopath is seeking a Senior Scientist / Principal Scientist to join our Assay R&D team and lead verification and validation activities for Nanopath’s diagnostic platform. This is a highly hands-on role, focused on assay integration onto Nanopath’s diagnostic platform. The role includes defining requirements, protocol development, experimental execution, statistical analysis, and writing reports. The Senior/Principal Scientist will partner with Engineering, Quality, and Regulatory to ensure studies and documentation support design control and regulatory submissions.

Requirements

• PhD or master’s degree in bioengineering, biomedical engineering, molecular biology, chemistry, or a 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.
• Extremely well-organized, with a high level of efficiency, attention to detail, and motivation for completing tasks accurately and on time.
• Excellent communication and presentation skills.
• Experience in cross-functional and highly collaborative work environments.
• Passionate about Nanopath’s mission for developing a purpose-built solution for women’s health.

Responsibilities

• Lead analytical verification and validation activities for Nanopath’s diagnostic platform, including study planning, protocol development, execution, analysis, and technical reporting.
• Translate product requirements into verification and validation strategies, study designs, predefined acceptance criteria, and risk-based testing approaches.
• Identify, investigate, and resolve assay and process performance issues, including unexpected results, sources of variability, and failure modes encountered during verification and validation.
• Apply statistical methods, design of experiments, and risk assessment tools to evaluate performance, identify failure modes, and support data-driven decisions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior