Senior Scientist, Diagnostic Platform V&V Lead

Nanopath Inc.; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Nanopath Inc. in Cambridge, MA is seeking a Senior Scientist / Principal Scientist to lead verification and validation for our diagnostic platform. This hands-on role includes defining requirements, protocol development, experimental execution, statistical analysis and reporting.

The role partners with Engineering, Quality and Regulatory to ensure studies support design control and regulatory submissions. PhD or MS with 5+ years in a regulated diagnostics environment is required.

Qualifications

• PhD or MS in a relevant field with 5+ years in industry.
• Experience with verification/validation in regulated diagnostics.
• Familiarity with design control and GLP/GxP documentation.
• Experience with nucleic acid assays, biosensors, or microarrays.

Responsibilities

• Lead analytical verification and validation activities for the diagnostic platform.
• Translate product requirements into verification/validation strategies and study designs.
• Identify and resolve assay/process performance issues and variability.
• Apply statistics and risk assessment to support data-driven decisions.

Skills

Verification & Validation

Design Control

Nucleic Acid Assays

GLP/GxP Principles

Communication Skills

Cross-functional Collaboration

Education

PhD or master’s degree in bioengineering, biomedical engineering, molecular biology, chemistry, or related field

Job description

Nanopath Inc. in Cambridge, MA is seeking a Senior Scientist / Principal Scientist to lead verification and validation for our diagnostic platform. This hands-on role includes defining requirements, protocol development, experimental execution, statistical analysis and reporting.

The role partners with Engineering, Quality and Regulatory to ensure studies support design control and regulatory submissions. PhD or MS with 5+ years in a regulated diagnostics environment is required.