Staff Engineer, Lab Operations

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

About the Role:

To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Post Deployment Development Team is seeking a highly motivated Engineer to help support the evolution of the Guardant Health Shield product/assay from its current state into a high throughput production line. The Staff Engineer, Lab Operations, will contribute to analyze current Shield operations workflows and recommendations areas for process improvement. 

As a Staff Engineer, you will support Shield Clinical Lab Operations, interface cross functionally, with members of various departments including Technology Development, Quality Assurance, Bioinformatics, and Automation Clinical Development. This position will contribute to project planning, continuous improvement activities, and process troubleshooting. They will drive changes to improve and support operations and establish additional capabilities such as: improved lab workflows, assembly methods, Turn-Around-Time, cost reduction, cost management etc.  An ideal candidate would have a high level of knowledge of Assay/Process development and good documentation practice (GDP). 

Essential Duties and Responsibilities:

• Serve as a liaison between Operations, Technology Development, Automation, etc. 

• Advocate for the needs of the Lab Operations department. 

• Collaborate with all functions within project teams. 

• Analyze data and troubleshoot issues with cross functional team members. 

• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 

• Drive continuous improvement within Screening Operations to reduce test turnaround time, analyze & reduce COGS, and improve product quality. 

• Determine and implement effective ways to create and execute improvement plans for Guardant Health’s screening product. 

• Present updates, write protocols, reports, and SOPs. 

• Support a Quality first culture by initiating and supporting the improvement and continuation of initiatives driving accuracy and consistent adherence to regulations. 

• Have a ‘change-agent’ mindset. 

Qualifications

• BS degree in Molecular Biology, Biochemistry, Engineering, or related discipline. 

• 8+ years’ experience in the Biotech/Pharmaceutical/Diagnostics Industry with expertise in manufacturing operations, process development, and process troubleshooting. 

• Must be able to work cross functionally in teams, or with individuals, on designated projects, to help clients and operators achieve sustainable results. 

• Proficient in biological sample handling as needed (i.e. tissue, blood, biofluid, etc.). 

• Data analysis, visualization, and reporting skills utilizing various software applications. 

• Molecular biology lab skills: Nucleic Acid Isolation, PCR preparation, and NGS Sequencing 

• Excellent written and oral communication skills. 

• Experience with process automation for nucleic acid extraction, NGS sample preparation assays, and sequencing platforms is a plus. 

• Highly skilled in visualization tools, SharePoint, Microsoft Office (Word, PowerPoint, Excel, Visio, Project). 

• Experience with development under FDA regulated environment is a plus 

• Experience with data analysis in JMP, R, and python is a plus 

Additional Information

Hybrid Work Model: At Guardant Health, we have 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 cr