V&V Senior Scientist / Principal Scientist
Nanopath
Cambridge
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.
Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Nanopath we are dedicated to building a diverse and inclusive workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every point in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles!
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.
Nanopath does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Nanopath, and Nanopath will not owe any referral or other fees with respect thereto.
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