IVD Assay Characterization & Validation Consultant

Cynet Systems • Indianapolis, IN

7d

About The Position

We are seeking an IVD Assay Characterization & Validation Consultant to drive technical characterization, execution, analytical verification, and regulatory documentation for automated clinical chemistry assays. The consultant will translate complex biochemical assays into scalable, manufactured diagnostic products and support a large-scale commercial point-of-care IVD product launch.

The role involves developing and executing CLSI-compliant validation protocols, operating automated clinical chemistry analyzers, conducting multi-method matrix characterization, analyzing validation data, and preparing technical documentation for the Design History File and FDA Pre-Submission (Q-Sub) materials. The consultant will also help frame technical and regulatory questions for FDA interactions regarding matrix expansion and validation scope.

This is described as a flexible consulting/contract arrangement, with hourly or project-based compensation and the possibility of expanded technical leadership or long-term collaboration.

Requirements

• Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or a related discipline.
• At least 2 years of experience in IVD assay development, characterization, and method validation within a regulated quality environment (FDA 21 CFR 820 / ISO 13485).
• Deep, practical knowledge of CLSI standard methodologies.
• Hands-on experience operating automated clinical chemistry analyzers.
• Working knowledge of FDA 510(k) matrix expansion strategies and the Q-Sub process.
• Ability to bridge theoretical chemistry and commercial IVD manufacturing requirements.
• Strong practical troubleshooting ability on benchtop and automated platforms.
• Exceptional experimental discipline, data integrity, and attention to detail.
• Ability to communicate complex analytical findings to scientific, engineering, and regulatory teams.
• Self-directed approach and ability to work in a fast-paced, milestone-driven product development environment.

Nice To Haves

• Cobas analyzer experience is strongly preferred.

Responsibilities

• Author, review, and finalize clinical validation protocols aligned with CLSI guidelines.
• Establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrix applications.
• Design iterative experiments to characterize precision, linearity, interferents, stability, and matrix dynamics.
• Operate, calibrate, and execute testing on automated clinical chemistry platforms, particularly Cobas systems.
• Conduct multi-day evaluations, including 20-day EP05 protocols, spike-and-recovery assessments, and serial dilution series.
• Mentor and train laboratory staff on platform SOPs, clinical protocols, and standardized analytical techniques.
• Lead method comparison studies evaluating candidate assays against primary and secondary reference standards.
• Investigate and resolve matrix phenomena, surface tension variations, fluidic behavior, and recovery bias in protein-free aqueous solutions.
• Conduct assay characterization cycles to define Limits of Detection/Quantitation (LoD/LoQ) and Analytical Measuring Ranges (AMR).
• Analyze raw datasets using validation software to develop statistical models, recovery plots, and bias metrics.
• Draft Method Validation Reports (MVRs) for the Design History File (DHF) and regulatory filings.
• Compile analytical performance packages for FDA Pre-Submission (Q-Sub) documentation.
• Develop strategic technical and regulatory questions for FDA Q-Sub interactions concerning matrix expansion and validation scope.

Benefits

• Competitive hourly or project-based compensation.
• Potential for expanded technical leadership or long-term collaboration.

What This Job Offers

• Career Level: Mid Level
• Education Level: Ph.D. or professional degree