Staff Engineering- Laboratory Operations

Guardant Health•Palo Alto, CA

1d•Hybrid

About The Position

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, position will contribute to analyzing current Shield operations workflows and recommend areas for process improvements. This role is based in Redwood City, CA and Palo Alto, CA. As a Staff Engineer, you will support Shield Clinical Lab Operations and interface cross functionally with members of various departments including Technology Development, Quality Assurance, Bioinformatics, Continuous Improvement, and Automation Clinical Development. This position will be responsible for developing, maintaining and using process monitoring tools to continuously improve the performance of our tests, generating regulatory compliant scale-up, Verification/Validation, and tech transfer procedures, the development and validation of process changes to enhance Shield performance, and leading efforts to integrate automation, LIMS, and Technology Development to improve the operations of the clinical laboratory. An ideal candidate would have a high level of knowledge of Assay/Process/Method development and good documentation practice (GDP).

Requirements

BS degree in engineering or science, preferably in bioengineering, chemical engineering, molecular biology, genetics, biochemistry, or a related discipline, and 8+ years of related experience. MS with 6+ years of related work experience or a PhD with 3+ years of related work experience will also be considered.
Must be able to work cross functionally in teams, or with individuals, on designated projects, to help clients and operators achieve sustainable results.
Experience in streamlining workflows and developing automated laboratory processes and instrumentation systems, including collecting and documenting requirements, developing concepts, assessing multiple proposals and choosing the one with the highest chance of success, design, testing/validation, implementing, and training.
Experience with operating and programming liquid handling robotics platforms (Hamilton, TECAN, Beckman, Agilent).
Experience with standard molecular biology techniques such as nucleic acid isolation, purification and quantitation, bioanalyzer, DNA/RNA quantitation, qPCR or next generation sequencing.
Proficient in biological sample handling as needed (i.e. tissue, blood, biofluid, etc.).
Data analysis, visualization, and reporting skills utilizing various software applications.
Excellent written and oral communication skills.
Highly skilled in visualization tools, SharePoint, Microsoft Office (Word, PowerPoint, Excel, Visio, Project).

Nice To Haves

Experience with development under FDA regulated environment is a plus.
Experience with data analysis in JMP, R, and python is a plus.

Responsibilities

Act as a strategic liaison between Operations, Technology Development, Automation, and other cross-functional partners to drive alignment and execution.
Lead or contribute to the design, development, optimization, and implementation of automated liquid handling processes, systems, and streamlined workflows.
Program robotic liquid handling workstations and integrated robotic systems.
Drive continuous improvement within Screening Operations by analyzing workflows, identifying bottlenecks, and developing solutions to reduce test turnaround time, reduce COGS, and improve efficiency, and product quality.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Advocate for the needs of the Lab Operations department.
Collaborate with all functions within project teams.
Drive collection of process requirements from cross-functional stakeholders.
Develop and present updates, author 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.