IVD Assay Characterization & Validation Consultant

The Fountain Group; Indianapolis (IN); Hybrid; USD 61,000 - 87,000; Full time

Job summary

The Fountain Group in Indianapolis, IN is seeking an IVD Assay Characterization & Validation Consultant on a 1-year contract with potential extension. You will drive technical characterization, CLSI-compliant validation, and regulatory documentation for automated clinical chemistry assays on Roche Cobas systems.

You will develop and execute CLSI protocols, manage analyzer operations, and author FDA Pre-Submission (Q-Sub) documentation.

Qualifications

• Clinical chemistry or related degree required.
• 2+ years in regulated IVD development.
• Experience with CLSI validation protocols.

Responsibilities

• Drive technical characterization and CLSI-compliant validation for automated clinical chemistry assays.
• Lead analyzer operations and bench execution on Roche Cobas platforms.
• Develop and author FDA Pre-Submissions (Q-Sub) documentation.
• Mentor staff and design iterative validation workflows.
• Frame regulatory questions for FDA Q-Sub interactions.

Skills

CLSI Knowledge

Instrumentation

Regulatory Knowledge

Education

B.S./M.S./Ph.D. in Clinical Chemistry or related field

Tools

Roche Cobas systems

Validation software

Job description

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Details for the positionare as follows:

• Location, Indianapolis, IN: Hybrid Schedule flexibility 3 days on site and 2 days remote - Depending on Job Duties.


• Open to candidates who are able to relocate at there own expense 2-3 weeks after an offer.


• Rate: $54 an hour.


• 1 year contract to start with the possibility of extension or conversion depending on performance and business needs.

Job Description:

• 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).


• Experimental Design & CLSI Protocol Development


• 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.


• Analyzer Operations & Bench Execution


• Lead hands‑on operation, calibration, and execution on automated clinical chemistry platforms (specifically Roche 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.


• Assay Characterization & Method Comparison


• 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).


• Data Analysis & Regulatory Documentation


• 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.

Required Skills:

• B.S., M.S., On-going Ph.D or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or a related discipline.


• Industry Experience: 2+ years in IVD assay development, characterization, and method validation within a regulated quality environment (FDA 21 CFR 820 / ISO 13485).


• CLSI Fluency: Deep, practical knowledge of CLSI standard methodologies.


• Instrumentation: Direct, hands‑on experience operating automated clinical chemistry analyzers (Roche Cobas experience strongly preferred).


• Regulatory Familiarity: Working knowledge of FDA 510(k) matrix expansion strategies and the Q‑Sub process preferred

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