Scientist, IVD Product Development & Validation

Predicine, Inc•Hayward, CA

11d•Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.