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

Minimum Preferred

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.

Apply today and help us turn breakthrough science into better patient outcomes.