Senior IVD Assay Validation Specialist (Hybrid)

Talentburst,-Inc; Indianapolis (IN); Ibrido; USD 83.000 - 165.000; Part-time

Vantaggi offerti da questo lavoro

Flexible consulting/contract terms

Competitive hourly or project-based‑

Direct contribution to large scale IVD

Descrizione del lavoro

Roche Diagnostics in Indianapolis is seeking an IVD Assay Characterization & Validation Consultant to drive technical characterization, CLSI-compliant validation, and regulatory documentation for automated clinical chemistry assays. This role combines hands-on bench work with cross-functional collaboration across regulatory, QA, and manufacturing teams.

You will lead multi-method matrix studies, author technical packages for FDA Q-Sub submissions, and mentor staff while ensuring quality and

Competenze

• BS/MS/PhD in a relevant field with hands-on IVD experience.
• 2 years in assay development and method validation within regulated environments.
• Strong CLSI methodology knowledge.

Mansioni

• Design CLSI-compliant validation protocols for automated chemistry assays.
• Lead analyzer operations and bench execution on Roche Cobas platforms.
• Draft MVRs and regulatory documentation for FDA Q-Sub submissions.
• Mentor staff on SOPs and analytical techniques.

Conoscenze

CLSI Protocol Development

Analytical Verification

Data Analysis & Statistics

Regulatory Documentation

Laboratory Operations

Formazione

Bachelor/Master in Clinical Chemistry, Biochemistry, Biomedical Engineering

PhD in related discipline (optional)

Strumenti

Roche Cobas analyzers

Validation Software (statistical tools)

Descrizione del lavoro

Roche Diagnostics in Indianapolis is seeking an IVD Assay Characterization & Validation Consultant to drive technical characterization, CLSI-compliant validation, and regulatory documentation for automated clinical chemistry assays. This role combines hands-on bench work with cross-functional collaboration across regulatory, QA, and manufacturing teams.

You will lead multi-method matrix studies, author technical packages for FDA Q-Sub submissions, and mentor staff while ensuring quality and