IVD Senior Scientist

Job Summary

A company is looking for a Senior IVD Scientist to join their Product Development team focused on early cancer detection.

Key Responsibilities

• Draft, review, and maintain technical documents including analytical validation protocols and reports
• Plan, manage, and document analytical validation studies in accordance with regulatory standards
• Coordinate study execution and analysis with lab and bioinformatics teams to ensure data integrity

Required Qualifications

• Ph.D. in Molecular Biology, Biochemistry, Genetics, or a related field
• Experience in analytical validation for IVDs, including documentation in line with CLSI guidelines
• Experience with FDA PMA submissions and Pre-Sub/Q-Sub interactions
• Proficiency in molecular biology and NGS, with the ability to troubleshoot assay performance issues
• Strong technical writing skills and ability to collaborate with cross-functional teams