IVD Senior Scientist

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