IVD Product Development & Validation Scientist

Predicine; Hayward (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Predicine is seeking a Scientist for IVD product development and validation in Hayward, CA. The role focuses on designing, executing, and analyzing analytical validation studies for Predicine's NGS-based IVD products, with close collaboration across Laboratory Operations, Quality, Regulatory, and Bioinformatics.

The ideal candidate has strong molecular biology/NGS experience, excellent attention to detail, and a drive to advance regulated diagnostics from lab to clinic.

Qualifications

• Experience designing and executing validation studies for NGS-based assays.
• Strong scientific writing for protocols, reports and regulatory documents.
• Ability to interpret complex data and troubleshoot validation results.

Responsibilities

• 30% Validation study design and execution per regulatory requirements.
• 20% Coordination of sample prep, testing, and data generation.
• 20% Prepare validation protocols and technical summaries.
• 20% Support regulatory submissions and data readiness.
• 10% Present results to cross-functional teams and stakeholders.

Skills

Experimental Design

Data Analysis

Troubleshooting

Lab Procedures

NGS Knowledge

Regulatory Awareness

Communication Skills

Urgency & Motivation

Education

PhD in Molecular Biology

Bachelor’s/Master with 3+ years experience

Tools

NGS Platforms

Job description

Predicine is seeking a Scientist for IVD product development and validation in Hayward, CA. The role focuses on designing, executing, and analyzing analytical validation studies for Predicine's NGS-based IVD products, with close collaboration across Laboratory Operations, Quality, Regulatory, and Bioinformatics.

The ideal candidate has strong molecular biology/NGS experience, excellent attention to detail, and a drive to advance regulated diagnostics from lab to clinic.