Senior IVD Scientist

Job Summary

A company is looking for a Senior IVD Scientist.

Key Responsibilities

• Draft, review, and maintain high-quality technical documents including analytical validation protocols and standard operating procedures
• Plan and document development and analytical validation studies in alignment with regulatory standards and CLSI guidelines
• Coordinate the execution and analysis of studies with lab and biostatistics teams, ensuring complete and traceable data packages

Required Qualifications

• Ph.D. in Molecular Biology, Biochemistry, Genetics, or a related field
• Experience in analytical validation for an IVD, including planning and execution of AV/V&V studies
• Experience contributing to FDA PMA submissions for an IVD, including Pre-Sub/Q-Sub submissions
• Experience with molecular biology and NGS; ability to interpret NGS assay performance metrics
• Proficiency in the interpretation and documentation of study results