IVD NGS Scientist – Validation & Regulatory Support

ADP, Inc.; Hayward (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Predicine Inc. is seeking a Scientist to support development, analytical validation, and regulatory submission of NGS-based IVD products.

The role involves designing validation studies, data interpretation, and technical documentation in collaboration with Laboratory Operations, Quality, Regulatory, and Bioinformatics teams. The ideal candidate has strong molecular biology/NGS experience, meticulous experimental skills, and a genuine interest in regulated IVD product development.

Qualifications

• PhD in Molecular Biology or Bachelor's/Master's with 3+ years of applicable technical experience.
• Experience with NGS or oncology is preferred.
• Familiarity with FDA and other regulatory guidelines for validations.

Responsibilities

• Design and execute validation studies for NGS-based IVD assays per design control and regulatory requirements.
• Coordinate sample preparation, testing, and data generation to meet timelines.
• Prepare and maintain validation protocols, reports, and technical summaries; ensure traceability.
• Support regulatory submissions with organized validation data and documentation.
• Present validation results to cross-functional teams and collaborate with Regulatory and Quality.

Skills

Experimental design

Data organization

Laboratory procedures

Critical thinking

NGS knowledge

Regulatory guidelines familiarity

Reading/communication

Self-motivation

Education

PhD in Molecular Biology

Bachelor's/Master's with 3+ years experience

Job description

Predicine Inc. is seeking a Scientist to support development, analytical validation, and regulatory submission of NGS-based IVD products.

The role involves designing validation studies, data interpretation, and technical documentation in collaboration with Laboratory Operations, Quality, Regulatory, and Bioinformatics teams. The ideal candidate has strong molecular biology/NGS experience, meticulous experimental skills, and a genuine interest in regulated IVD product development.