Senior Scientist- Technology Development

Guardant Health-posted 3 months ago
$129,600 - $178,200/Yr
Full-time • Senior
Palo Alto, CA
1,001-5,000 employees
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The Senior Scientist will support assay development and validation with the goal of helping launch new products. The scientist will lead analytical performance testing, support clinical validation studies, and interface with lab directors, other technology development staff, bioinformatics, engineering, quality, regulatory, and product groups to support product development. The scientist will have opportunities to assist in the product development, transfer of assay to the clinical laboratory and post-launch support of the products.

  • 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, NYSDOH).
  • 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 NGS diagnostic 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 mentorship and technical guidance to junior staff or cross-functional team members as needed.
  • Advanced degree in Molecular Biology, Genetics, Biochemistry, or related field (PhD preferred).
  • PhD with 5–8 years of industry experience or MS with 10–12 years of industry experience.
  • Strong background in assay development; NGS-based assays highly preferred.
  • Experience with assay validation (IVD validation and regulatory defense a plus).
  • Product development expertise, including technology transfer and troubleshooting.
  • Excellent documentation skills (study protocols, technical reports).
  • Strong communication and collaboration skills.
  • Detail-oriented, organized, and self-driven.
  • Familiarity with statistical analysis and bioinformatics analysis of NGS data desired.
  • Quick learner who enjoys multi-tasking.
  • Interest in oncology diagnostics and patient care.
  • Base salary range for this full-time position is $129,600 to $178,200.
  • Hybrid Work Model with defined days for in-person collaboration and work-from-home days.
  • Flexibility for better work-life balance.
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