NGS IVD Product Development & Validation Scientist

Predicine, Inc; Hayward (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Predicine Inc. is seeking a highly motivated Scientist for IVD product development and validation in Hayward, CA.

The role focuses on designing analytical validation studies for NGS-based assays and coordinating cross-functional activities with Regulatory, Quality, and Bioinformatics teams. Ideal candidates have strong molecular biology/NGS background, solid data interpretation skills, and experience navigating regulatory guidelines for diagnostics.

Qualifications

• Design, execute validation studies for NGS-based IVD assays per regulatory guidelines.
• Prepare validation protocols, reports, and technical summaries with traceability.
• Support regulatory submissions with complete documentation and data support.

Responsibilities

• Design and execute validation studies for NGS-based IVD assays.
• Coordinate sample prep, testing, and data generation to meet timelines.
• Prepare and maintain validation protocols, reports, and technical summaries.
• Support preparation of regulatory submission documentation and data packages.
• Present validation results to cross-functional teams and stakeholders.

Skills

Experiment design

Data organization

Result interpretation

NGS knowledge

Molecular biology

Cancer biology

Regulatory familiarity

Communication

Self-motivation

Troubleshooting

Education

PhD in Molecular Biology

Bachelor's/Master with 3+ years experience

Tools

Laboratory instruments

Job description

Predicine Inc. is seeking a highly motivated Scientist for IVD product development and validation in Hayward, CA.

The role focuses on designing analytical validation studies for NGS-based assays and coordinating cross-functional activities with Regulatory, Quality, and Bioinformatics teams. Ideal candidates have strong molecular biology/NGS background, solid data interpretation skills, and experience navigating regulatory guidelines for diagnostics.