Senior Scientist / Principal Scientist, Verification and Validation

Job overview

The Senior Scientist / Principal Scientist, Verification and Validation role is onsite in Cambridge, MA, with compensation not specified. The role is part of Nanopath’s Assay R&D team, developing an in vitro diagnostics platform intended to bring rapid diagnostic results closer to patients. The scientist leads verification and validation activities for the diagnostic platform, translating product requirements into study plans, protocols, acceptance criteria, and risk-based testing. The work supports design control and regulatory submissions through experimental execution, statistical analysis, and technical reporting in collaboration with Engineering, Quality, and Regulatory.

What you'll do

• Lead analytical verification and validation study planning, protocol development, execution, analysis, and reporting
• translate product requirements into V&V strategies and acceptance criteria
• investigate assay and process performance issues and sources of variability
• apply statistical methods, design of experiments, and risk assessment tools.

What we're looking for

Skills & competencies

senior scientist

principal scientist

verification and validation

assay r&d

diagnostics

in vitro diagnostics

cambridge ma

nanopath

design control

regulatory submissions

statistical analysis

Work arrangement

• Weekend coverage required

Why this role

The role combines hands-on assay integration and regulated diagnostic product development with cross-functional work supporting design control and regulatory submissions.

About the employer

Nanopath is hiring for this role. Industry: In-Vitro Diagnostic Substance Manufacturing. Sector: 32.