US_IVD Assay Characterization & Validation Consultant _CO

The Fountain Group is currently seeking an IVD Assay Characterization & Validation Consultant for a prominent client of ours. This position is located in Indianapolis, IN – Hybrid. Details for the position are as follows:

Job Title: IVD Assay Characterization & Validation Consultant
Location: Indianapolis, IN – Hybrid, 3 days onsite / 2 days remote depending on job duties
Pay Rate: $53/hour
Duration: 1 year

• Develop, execute, and document analytical characterization and validation studies for automated clinical chemistry assays.
• Author and review CLSI-compliant clinical validation protocols and analytical acceptance criteria.
• Design studies for precision, linearity, interferents, stability, matrix effects, spike-and-recovery, and serial dilution.
• Operate and calibrate automated clinical chemistry analyzers, including Roche Cobas platforms.
• Execute multi-day validation protocols, including EP05 evaluations.
• Conduct assay method comparisons against primary and secondary reference standards.
• Characterize LoD, LoQ, and Analytical Measuring Range (AMR).
• Perform statistical analysis of validation datasets, including recovery plots, bias metrics, and statistical models.
• Author Method Validation Reports (MVRs) and analytical performance documentation for Design History Files (DHF) and regulatory submissions.
• Prepare technical documentation supporting FDA Pre-Submission (Q-Sub) interactions and matrix expansion strategies.

• B.S., M.S., ongoing Ph.D., or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related scientific discipline.

• 2+ years of IVD assay development, characterization, and method validation.
• Experience in regulated IVD/diagnostics environments.
• Practical knowledge of CLSI standard methodologies.
• Hands-on experience with automated clinical chemistry analyzers.
• Experience with analytical verification and assay characterization.
• Experience with precision, linearity, interferent, stability, and matrix studies.
• Experience with method comparison studies and reference methods.
• Experience determining LoD/LoQ and AMR.
• Statistical analysis of assay validation data.
• Experience with clinical/analytical validation protocols and validation reports.
• Knowledge of FDA 21 CFR 820 and ISO 13485 requirements.

• Hands-on Roche Cobas analyzer experience.
• FDA 510(k) matrix expansion experience.
• FDA Q-Sub process experience.
• Experience preparing analytical performance packages for regulatory submissions.
• Experience with Design History Files (DHF).
• Experience with protein-free aqueous matrices, recovery bias, surface tension, and fluidic behavior characterization.
• Experience mentoring laboratory staff on clinical chemistry platforms, SOPs, and analytical validation procedures.