US_IVD Assay Characterization & Validation Consultant _CO

The Fountain Group; Indianapolis (IN); Hybrid; USD 73,000 - 83,000; Full time

Job summary

The Fountain Group is seeking an IVD Assay Characterization & Validation Consultant for a hybrid, Indianapolis-based role. The position involves developing and validating automated clinical chemistry assays, writing CLSI-compliant validation protocols, and supporting regulatory submissions.

Requirements include a BS/MS/PhD in a relevant field and 2+ years in regulated IVD environments with hands-on experience on automated analyzers. This is a 1-year contract with pay at $53/hour.

Qualifications

• 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.

Responsibilities

• 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.

Skills

IVD assay development

Characterization

Method validation

Regulated IVD environments

CLSI standards

Automated analyzers

Statistical analysis

Validation reporting

FDA 21 CFR 820

ISO 13485

Education

Bachelor’s/ MS/ PhD in Clinical Chemistry/Biochemistry/Biomedical Engineering

B.S./M.S./Ph.D. in related field

Tools

Roche Cobas

Job description

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

Job Description

• 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.

Education

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

Required Skills

• 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.

Preferred Skills

• 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.

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