IVD Validation Scientist

Job Description

Job Description

Responsibilities:

• Experimental Design & CLSI Protocol Development: Author, review, and finalize clinical validation protocols aligned with CLSI guidelines. Establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrices. Design iterative studies for precision, linearity, interferents, stability, and matrix dynamics.
• Analyzer Operations & Bench Execution: Lead operation, calibration, and execution on automated clinical chemistry platforms, with emphasis on Roche Cobas systems. Perform multi-day evaluations such as 20-day EP05 protocols, spike-and-recovery assessments, and serial dilutions. Mentor and train staff on SOPs and analytical techniques.
• Assay Characterization & Method Comparison: Lead method comparison studies against primary and secondary reference standards. Investigate matrix phenomena, surface tension, fluidic behavior, and recovery bias in protein-free aqueous solutions. Define LoD, LoQ, and AMR through iterative characterization cycles.
• Data Analysis & Regulatory Documentation: Perform statistical analysis using validation software to generate models, recovery plots, and bias metrics. Draft Method Validation Reports for the Design History File and regulatory use. Compile analytical performance packages and frame questions for FDA Q-Sub interactions.

Required Skills & Qualifications:

• Education: B.S., M.S., On-going Ph.D, or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related field.
• Industry Experience: 2+ years in IVD assay development, characterization, and method validation within a regulated environment (FDA 21 CFR 820 / ISO 13485).
• CLSI Fluency: Practical knowledge of CLSI standard methodologies and study designs.
• Instrumentation: Hands-on experience with automated clinical chemistry analyzers; Roche Cobas preferred.
• Regulatory Familiarity: Understanding of FDA 510(k) matrix expansion strategies and the Q-Sub process.