About this opportunity
Consultant Specialists, Inc. (CSI) lists this Ivd Assay Characterization & Validation Consultant opportunity in township of perry, Indiana. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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)
Execute multi‑day protocols (e.G., EP05), spike‑and‑recovery, and dilution workflows
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
Self‑directed, detail‑driven, and comfortable in fast‑paced development settings
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.
Worksite address
township of perry, IN, 46262, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.