V&V Senior Scientist / Principal Scientist

Nanopath Inc.; Cambridge (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Nanopath Inc. seeks a Senior/Principal Scientist to lead verification and validation for its in vitro diagnostic platform.

The role is hands-on, shaping requirements, protocols, experiments, statistics, and reports while collaborating with Engineering, Quality, and Regulatory to support design control and regulatory submissions. The candidate will drive analytical verification/validation, identify failure modes, and apply DOE and statistics to ensure robust performance for a women’s

Qualifications

• PhD or master's in bioengineering, biomedical engineering, molecular biology, chemistry, or related field with 5+ years of industry experience.
• Experience with verification and validation in regulated diagnostic product development.
• Familiarity with design control, quality systems, GLP/GxP principles, or documentation practices for regulated diagnostics.
• Experience with nucleic acid assays, biosensors, and/or microarrays.
• Highly organized with strong attention to detail and ability to complete tasks on time.
• Excellent communication and presentation skills.
• Collaborative, cross-functional team player with a passion for women’s health.

Responsibilities

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

Skills

Verification & validation

Design control

Quality systems

GLP/GxP knowledge

Communication skills

Education

PhD or Master's in bioengineering

Job description

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.

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.

Qualifications

• 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.

Nanopath Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.