Staff Engineer, Lab Operations

3 weeks ago

Redwood City, California, United States Guardant Health Full time
Job Title: Staff Engineer, Lab Operations

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through the use of its proprietary tests, vast data sets, and advanced analytics. We are seeking a highly motivated Staff Engineer, Lab Operations to support the evolution of the Guardant Health Shield product/assay from its current state into a high-throughput production line.

About the Role:

The Staff Engineer, Lab Operations will contribute to analyzing current Shield operations workflows and recommending areas for process improvement. This role will support Shield Clinical Lab Operations, interface cross-functionally with members of various departments, including Technology Development, Quality Assurance, Bioinformatics, and Automation Clinical Development.

Key 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.
Requirements:
  • 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 environments is a plus.
  • Experience with data analysis in JMP, R, and Python is a plus.

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