Hybrid IVD Assay Validation Scientist – Indianapolis

Consultant Specialists, Inc. (CSI); Indianapolis (IN); Híbrido; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

CLSI fluency

Automated analyzers

Regulatory collaboration

Data analysis & statistics

Validation in FDA/ISO environments

Formação académica

BS/MS/PhD in Clinical Chemistry or related field

Ferramentas

Cobas analyzers

Descrição da oferta de emprego

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.