IVD Assay Characterization and Validation Consultant

TalentBurst•Indianapolis, IN

6d•Hybrid

About The Position

We are seeking an IVD Assay Characterization & Validation Consultant to drive the technical characterization, execution, analytical verification, and regulatory documentation for automated clinical chemistry assays. This role requires a hands-on scientist with a proven track record of translating complex biochemical assays into scalable, manufactured diagnostic products. You will spearhead CLSI-compliant validation protocols, manage analyzer operations, lead multi-method matrix characterizations, and author technical packages for FDA Pre-Submissions (Q-Sub).

Requirements

B.S., M.S., On-going Ph.D or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or a related discipline.
2 years 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.
Direct, hands-on experience operating automated clinical chemistry analyzers (Client Cobas experience strongly preferred).
Working knowledge of FDA 510(k) matrix expansion strategies and the Q-Sub process.
Demonstrated ability to bridge theoretical chemistry and commercial IVD manufacturing requirements.
Strong, practical troubleshooting capability on benchtop and automated platforms.
Exceptional experimental discipline, data integrity, and attention to detail.
Ability to distill complex analytical findings into actionable insights for scientific, engineering, and regulatory teams.
Self-directed operator who thrives in a fast-paced, milestone-driven product development environment.

Nice To Haves

Client Cobas experience strongly preferred

Responsibilities

Author, review, and finalize formal clinical validation protocols in strict alignment with CLSI guidelines.
Establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrix applications.
Design iterative experimental workflows to characterize precision, linearity, interferents, stability, and matrix dynamics.
Lead hands-on operation, calibration, and execution on automated clinical chemistry platforms (specifically Client Cobas systems).
Perform complex multi-day evaluations (e.g., 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.
Spearhead method comparison studies evaluating candidate assays against primary and secondary reference standards.
Investigate and resolve complex matrix phenomena, surface tension variations, fluidic behavior, and recovery bias in protein-free aqueous solutions.
Conduct iterative assay characterization cycles to define Limits of Detection/Quantitation (LoD/LoQ) and Analytical Measuring Ranges (AMR).
Perform statistical analysis on raw datasets using specialized validation software to build statistical models, recovery plots, and bias metrics.
Draft comprehensive Method Validation Reports (MVRs) for inclusion in the Design History File (DHF) and regulatory filings.
Compile analytical performance packages for FDA Pre-Submission (Q-Sub) documentation.
Frame strategic technical and regulatory questions for FDA Q-Sub interactions regarding matrix expansion and validation scope.