IVD Assay Validation Specialist - CLSI & Regulatory

Planet Pharma; Indianapolis (IN); On-site; USD 83,000 - 152,000; Part time

Job summary

Planet Pharma seeks an IVD Assay Characterization & Validation Consultant to drive technical characterization, validation, and regulatory documentation for automated clinical chemistry assays. This hands-on scientist will translate complex assays into scalable diagnostic products, lead CLSI‑compliant validations, manage analyzer operations, and author regulatory packages for FDA Pre-Submissions.

Ideal candidates will have 2+ years in regulated IVD environments, hands-on Cobas experience, and

Qualifications

• BS/MS/PhD in a relevant science field or ongoing PhD.
• 2+ years in IVD assay development, characterization, and validation in regulated environments.
• Strong CLSI knowledge and practical application in validation.
• Experience with FDA pre-submissions and Q-Sub processes is a plus.

Responsibilities

• Design CLSI-compliant validation protocols.
• Lead analyzer operations and multi-method matrix characterizations.
• Draft Method Validation Reports and regulatory documentation.
• Collaborate with cross-functional teams to frame regulatory questions.

Skills

Translational mindset

Analytical problem-solver

Scientific rigor

Cross-functional communicator

Autonomy

Cobas systems

CLSI methodologies

FDA Q-Sub familiarity

Education

B.S., M.S., or Ph.D. in clinical chemistry, biochemistry, biomedical engineering

Tools

Cobas systems

Job description

Planet Pharma seeks an IVD Assay Characterization & Validation Consultant to drive technical characterization, validation, and regulatory documentation for automated clinical chemistry assays. This hands-on scientist will translate complex assays into scalable diagnostic products, lead CLSI‑compliant validations, manage analyzer operations, and author regulatory packages for FDA Pre-Submissions.

Ideal candidates will have 2+ years in regulated IVD environments, hands-on Cobas experience, and