Scientist I

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012 Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care including screening to find cancer early monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information visitand follow the company onLinkedInX (Twitter)andFacebook.

Department Summary

The Technology Development Department is responsible for developing validating implementing and maintaining the tests used by Guardant Health for cancer detection. This role sits in Sustain & Support (S&S) within Technology Development partnering tightly with Clinical Operations to triage and resolve clinical failures develop and improve reagent QC systems to reduce recurring failures and optimize on-market liquid and tissue assays under regulated quality systems. Within S&S we optimize deployed methods when quality issues arise develop PQ strategies scale manufacturing processes and drive sustaining projects under design control. This team operates at the intersection of assay bioinformatics operations and quality serving as the link across functions to sustain robust clinical production.

Position Summary

The Scientist I in S&S will help ensure the reliability and continuous improvement of Guardants on-market assays. This role will focus on investigating and resolving failures in clinical laboratory operations strengthening reagent QC systems to improve consistency and reduce repeat issues and supporting process validations in compliance with regulated quality systems. The Scientist I will combine wet-lab assay expertise laboratory and operational data analysis and structured quality-system investigation to identify root causes guide corrective actions and enhance product performance. They will work closely with Clinical Operations Bioinformatics Process Engineering Reagent QC Manufacturing and Quality teams to deliver durable fixes reduce QC failures and enable efficient technology transfer into addition the scientist will contribute to NCR and other quality-system investigations support validation and change-control documentation and provide ongoing technical support for sustaining and scaling Guardants assays.

Essential Duties and Responsibilities

• Draft and execute verification and validation protocols including IQ/OQ/PQ activities; contribute to design- and change-control packages and risk assessments; and support manufacturing process validation activities to production-grade standards.
• Operate and troubleshoot NGS workflows end to end including sample preparation library preparation target enrichment sequencing and medium- to high-throughput runs. Operate laboratory automation platforms as applicable and support instrument maintenance troubleshooting and defined method improvements.
• Partner with Technology Development and Bioinformatics to develop evaluate and implement assay and process improvements; execute structured transfers into Clinical Operations; and support the clinical laboratory post-transfer through troubleshooting training and controlled documentation.
• Analyze assay reagent QC sequencing and clinical operations data by integrating information from SQL databases flat files LIMS and other internal data sources. Use Python and Jupyter to identify trends test hypotheses and determine relationships between upstream process variables QC metrics and assay failures.
• Follow FDA and ISO 13485 quality-system standards and support structured investigations of assay reagent and process failures including root-cause analysis impact assessment evaluation of potential corrective actions and preparation of supporting documentation for NCRs change controls audit responses and related quality records. Maintain complete GDP-compliant records with full traceability.
• Present technical findings conclusions limitations and riskbenefit tradeoffs to laboratory leadership Bioinformatics Process and Manufacturing Engineering and Clinical Operations; write clear technical reports; and support cross-functional decision-making.
• Work location requirement: This role requires the employee to work onsite at both the Redwood City and Palo Alto offices based on business needs.

Qualifications

• PhD in Molecular Biology Genomics Biochemistry or related field or equivalent work experience.
• A minimum of 0-2 of related experience (post-doctoral research or relevant industry experience will be considered)
• Strong foundation in molecular biology including experience with NGS library preparation and target enrichment. Familiarity with circulating cell-free nucleic acid workflows is a plus.
• Experience operating NGS instruments and executing sample-preparation assays in medium- or high-throughput environments. Experience with process automation or liquid-handling platforms is preferred but not required.
• Strong data-analysis skills using Python and Jupyter for scripting automation and visualization with the ability to work across SQL tables flat files LIMS and other laboratory data sources. Experience analyzing assay reagent QC operational or sequencing datasets is strongly preferred. Familiarity with NGS bioinformatics outputs is an advantage.
• Experience designing executing or analyzing structured scientific studies with strong technical documentation and report-writing skills. Experience with verification validation manufacturing process studies or SOP/Work Instruction authorship is preferred.
• Excellent crossdiscipline communication and a track record of independent and teambased problem solving in fastpaced environments.
• Strong organization attention to detail and commitment to good documentation practices (GDP).
• Experience working under structured laboratory or quality-system requirements with an understanding of controlled documentation traceability deviation investigation and change management. Experience in FDA- CLIA- or ISO 13485-regulated environments is preferred.

AI & Digital Fluency

• Demonstrate curiosity sound judgment and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies ethical standards and regulatory requirements to improve the efficiency effectiveness and quality of work.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or if applicable bonus commission or equity. Each candidates compensation offer will be based on multiple factors including but not limited to geography experience education job-related skills job duties and business need. Primary Location: Redwood City CA Primary Location Base Pay Range: $115200 - $158400 Other US Location(s) Base Pay Range: $97920 - $134640 If the role is performed in Colorado the pay range for this job is: $103680 - $142560