Scientist I

Guardant Health seeks a Scientist I to support the reliability and continuous improvement of oncology assays in a regulated laboratory environment. The role combines wet-lab expertise, data analysis, and quality-system investigation to resolve clinical failures, strengthen reagent QC, and enable process optimization across blood and tissue testing platforms.

Responsibilities

• Draft and execute verification and validation protocols including IQ/OQ/PQ activities and design control documentation
• Operate and troubleshoot end-to-end NGS workflows and laboratory automation platforms with troubleshooting support
• Analyze assay, reagent QC, and clinical operations data to identify trends and determine relationships between process variables and failures
• Support structured root-cause analyses and corrective actions for assay, reagent, and process failures under FDA/ISO standards
• Partner with Technology Development, Bioinformatics, and Clinical Operations to develop improvements and execute controlled transfers into production

Requirements

• PhD in Molecular Biology, Genomics, Biochemistry, or related field; equivalent work experience considered
• 0-2 years related experience in postdoctoral research or industry
• Strong molecular biology foundation with NGS library preparation and target enrichment experience
• Proficiency in Python and Jupyter for data analysis across SQL, LIMS, and flat-file sources
• Experience operating NGS instruments in medium- or high-throughput laboratory settings
• Knowledge of FDA and ISO 13485 quality systems and structured failure investigations
• Technical writing and cross-functional communication skills for regulatory and operational contexts