Scientist I - Technology Development

$95,200 - $128,500/Yr

Guardant Health - Redwood City, CA

Full-time - Entry Level

Remote - Redwood City, CA

Ambulatory Health Care Services

About the position

The Technology Development Scientist at Guardant Health plays a crucial role in supporting assay development and validation for cancer detection tests. This position focuses on leading analytical performance testing, supporting clinical validation studies, and collaborating with various teams to ensure successful product development and regulatory submissions. The scientist will engage in hands-on laboratory work and contribute to the transfer of assays to clinical laboratories, ultimately aiding in the launch of new products and companion diagnostics.

Responsibilities

• Design, execute, and analyze validation studies, ensuring clear and comprehensive documentation of results in compliance with Quality Systems and Good Laboratory Practices.
• Perform hands-on laboratory work, including the development, optimization, and troubleshooting of assays, devices, or technologies.
• Lead or contribute to the preparation of technical documentation and regulatory submissions, including device master records, risk assessments, and technical dossiers for regulatory bodies (e.g., FDA, CE marking, CAP/CLIA certifications).
• Manage project timelines, resources, and tasks, coordinating and presenting to both internal and external stakeholders to ensure timely and successful project execution.
• Stay current with advances in IVD technologies and regulatory guidelines, integrating best practices into product development and validation strategies.
• Ensure compliance with all relevant safety, ethical, and quality standards during product development and testing phases, especially as it relates to data integrity.
• Provide technical guidance to junior staff or cross-functional team members as needed.

Requirements

• Degree in Molecular Biology, Genetics, Biochemistry, or related field; PhD preferred, but Masters and Bachelors with a track record of performance in Scientist roles will be considered.
• Post-graduate industry experience in genomics or molecular biology.
• 0-3 years industry experience (assuming PhD).
• Strong documentation skills, especially writing study protocols and reports.
• Excellent interdisciplinary communication skills.
• Detail-oriented with good organization.
• Self-driven and a strong team player.

Nice-to-haves

• Experience with assay development, preferably next-generation sequencing-based assays.
• Experience with assay validation, IVD validation, and regulatory defense preferred.
• Experience with product development, including technology transfer and operational troubleshooting.
• Familiarity with statistical analysis and bioinformatics analysis of NGS data desired.
• Quick learner who enjoys multi-tasking.
• Interest in oncology diagnostics and patient care.

Benefits

• Hybrid work model with defined in-office collaboration days and work-from-home flexibility.
• Competitive salary range based on location and experience.
• Commitment to providing reasonable accommodations for candidates with disabilities or long-term conditions.