Scientist, IVD Product Development & Validation

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

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Scientist, IVD Product Development & Validation

Full Time Professional Hayward, CA, US

3 days ago Requisition ID: 1103

About Predicine Inc.

Predicine Inc. is a Silicon Valley-based global precision diagnostic company committed to developing first- and best-in-class liquid biopsy cancer diagnostics assays. We provide innovative blood- and urine-based molecular diagnostic tests to enable precision medicine. Predicine's liquid biopsy platform and molecular insight solutions help biopharma companies accelerate drug development and expand discovery in oncology. We partner with the top 10 leading global biopharma companies to support biomarker-driven clinical trials across the US, EU, and APAC, including China. At Predicine, we believe people are our most important asset, and we're dedicated to creating a great place to work — one built on creativity, integrity, accountability, productivity, and teamwork.

Job Summary

We are seeking a highly motivated Scientist to support the development, analytical validation, and regulatory submission of Predicine's NGS-based IVD products. This position will play a key role in designing and executing analytical validation studies, analyzing and interpreting validation data, preparing technical documentation, and supporting regulatory submissions. The scientist will work closely with cross-functional teams — including Laboratory Operations, Quality, Regulatory, and Bioinformatics — to ensure validation studies are scientifically sound, executed according to approved protocols, and completed within established timelines. The ideal candidate brings strong experience in molecular biology and/or NGS, excellent experimental and analytical skills, strong attention to detail, and genuine interest in applying scientific knowledge to regulated IVD product development.

What You'll Do

Key Responsibilities & Time Allocation

30% - Validation Study Design & Execution — Design and execute validation studies for NGS-based IVD assays in accordance with design control and applicable regulatory requirements; develop and review study protocols, experimental plans, and acceptance criteria based on intended use, product requirements, risk assessment, and regulatory expectations.

20% - Study Coordination & Data Generation — Coordinate sample preparation, laboratory testing, and data generation to ensure studies are executed according to approved protocols and timelines; support investigation and resolution of unexpected results, study deviations, and other validation-related issues.

20% - Technical Documentation — Prepare and maintain validation protocols, reports, technical summaries, and other product development documentation; ensure technical documents are scientifically accurate, complete, traceable, and consistent with applicable regulatory and quality requirements.

20% - Regulatory Submission Support — Support preparation of technical documentation required for regulatory submissions and reimbursement assessments; organize and maintain validation data and supporting documentation to ensure readiness for regulatory review.

10% - Cross-Functional Collaboration & Presentation — Present validation results and technical conclusions to cross-functional teams and stakeholders; work closely with Regulatory and Quality teams to ensure submission materials are complete, consistent, and aligned with applicable requirements.

Required Skills & Qualifications

• Strong skills in experimental design, data organization, and result interpretation
• Familiarity with laboratory procedures, SOPs, and instruments
• Critical thinking and effective troubleshooting skills
• Solid knowledge of NGS-related research areas such as NGS, molecular biology, genetics, cancer biology, or related areas
• Willingness to work in the lab and learn FDA and other regulatory authorities' guidelines on general principles related to validations
• Proficient reading and communication skills
• Highly self-motivated with a strong sense of urgency

Education

PhD in Molecular Biology or a closely related field or Bachelor's/Master's degree with 3+ years of applicable technical experience

Field of Study

Molecular Biology or closely related field

Experience Preferred

• PhD holders: no additional minimum experience specified
• Non-PhD candidates: 3+ years of technical experience in applicable areas such as NGS or oncology

Join Us

At Predicine, you won't just run experiments — you'll help bring regulated, first-of-their-kind cancer diagnostics from the lab to real-world clinical use. If you're detail-driven, scientifically rigorous, and want to make a direct impact on how cancer is diagnosed, we want to hear from you.

Predicine is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.