IVD Assay Characterization & Validation Consultant

Consultant Specialists, Inc. (CSI); Indianapolis (IN); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Consultant Specialists, Inc. (CSI) is seeking an hands-on IVD Assay Characterization & Validation Consultant in a hybrid role located in Indianapolis, IN.

You will lead validation efforts for automated clinical chemistry assays, translating complex methods into scalable, manufacturable products. Responsibilities include CLSI-aligned protocol development, study design for precision/linearity, data analysis with statistical models, and authoring necessary regulatory documentation.

Qualifications

• 2+ years in IVD assay development/validation in FDA/ISO-regulated environments.
• Strong CLSI fluency and hands-on experience with automated analyzers.
• Familiarity with FDA 510(k) matrix expansion and Q-Sub processes.
• Exceptional experimental rigor, analytical problem-solving, and data integrity.
• Ability to communicate complex findings across scientific, engineering, and regulatory teams.

Responsibilities

• Lead CLSI-aligned assay characterization and validation protocol development.
• Design studies for precision, linearity, interferents, stability, LoD/LoQ, and AMR.
• Operate and troubleshoot automated chemistry analyzers (Cobas experience preferred).
• Conduct method comparison studies and resolve complex matrix behavior issues.
• Analyze datasets using validation software; build statistical models and bias metrics.
• Author MVRs, DHF documentation, and FDA Q-Sub technical packages.
• Support regulatory strategy and frame technical questions for FDA interactions.
• Mentor lab staff on SOPs, protocols, and analytical best practices.

Skills

CLSI fluency

Automated analyzers

Regulatory collaboration

Data analysis & statistics

Validation in FDA/ISO environments

Education

BS/MS/PhD in Clinical Chemistry or related field

Tools

Cobas analyzers

Job description

IVD Assay Characterization & Validation Consultant

Hybrid – Indianapolis, IN (3 days onsite / 2 remote)

Seeking a hands‑on scientist to drive assay characterization, validation, and regulatory documentation for automated clinical chemistry assays. This role focuses on translating complex biochemical methods into scalable, manufacturable IVD products.

What You’ll Do

• Lead CLSI‑aligned assay characterization and validation protocol development
• Design studies for precision, linearity, interferents, stability, LoD/LoQ, and AMR
• Operate and troubleshoot automated chemistry analyzers (Cobas experience preferred)
• Conduct method comparison studies and resolve complex matrix behavior issues
• Analyze datasets using validation software; build statistical models and bias metrics
• Author MVRs, DHF documentation, and FDA Q‑Sub technical packages
• Support regulatory strategy and frame technical questions for FDA interactions
• Mentor lab staff on SOPs, protocols, and analytical best practices

What You Bring

• BS/MS/PhD in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related field
• 2+ years in IVD assay development/validation in FDA/ISO‑regulated environments
• Strong CLSI fluency and hands‑on experience with automated analyzers
• Familiarity with FDA 510(k) matrix expansion and Q‑Sub processes
• Exceptional experimental rigor, analytical problem‑solving, and data integrity
• Ability to communicate complex findings across scientific, engineering, and regulatory teams

About the Organization

Focused on advancing near‑patient diagnostic solutions that support diabetes management and continuous monitoring. The Indianapolis site manufactures high‑volume blood glucose monitoring products and is expanding into sensor manufacturing for next‑generation continuous glucose monitoring systems.