IVD Assay Validation Consultant — Hybrid (Indy)

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

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.