Associate Automation Scientist

Organization
Process Development - 59
Job Location
Redwood City, CA 94059
Job Description

The Associate Automation Scientist will be directly responsible for contributing to the development, optimization, and improvement of automated workflows used for and in support of existing and new diagnostic product development for tissue and fluid based assays for cancer patients. He or she will participate in all aspects of assay automation development from concept and requirements definition, manual assay development, to adaptation, optimization, troubleshooting and validation of assays on an automated platform. The Associate Automation Scientist will report directly to a Senior Automation Scientist in Process Engineering. The Associate Automation Scientist will work collaboratively in teams consisting of diverse disciplines including, research and development, process engineering, reagent quality, software development, biostatistics, data management, laboratory operations, and clinical quality to manage the development, optimization, and validation of automated processes, with an emphasis on systems integration and robustness. These cross functional teams will explore, develop, optimize, test, and implement robust, scalable solutions for Genomic Health’s sample processing workflows with attention to understanding business and user requirements and improving efficiency, throughput, and quality. These processes include nucleic acid extraction and quantification, NGS library preparation and sequencing, and quantitative PCR. Projects may include the evaluation of commercially available hardware and software. S/he will be expected, after training, to perform all laboratory procedures needed to process samples with our workflows to support process development and implementation activities. S/he will also be expected to to provide input to design, direction, implementation and interpretation of experimental studies. The Associate Scientist will also be responsible for contributing to protocol generation, report writing and presentation preparation.

  • Contribute as a team member to the design, develop, optimize, test, and implement automated processes, systems, and streamlined workflows for the clinincal laboratories, research & development laboratory, manufacturing group, and pathology group using DOE methodologies
  • Author protocols for studies and reports required for process development, improvement, or troubleshooting
  • Contribute as a team member to design and execute experiments in a timely manner with well-organized and documented analysis
  • Evaluate off the shelf robotic systems and optimize accordingly
  • Analyze workflows and develop new automated methods to address identified needs
  • Program robotic liquid handling workstations
  • Perform technology transfer from Engineering to end-users
  • Write and review IQ/OQ/PQ documentation, test plans and validation reports
  • Write and review experimental protocols and Standard Operating Procedures, incorporating input from other team members efficiently and effectively
  • Perform laboratory activities including nucleic acid extraction, reverse transcription, quantitative PCR and next generation sequencing utilizing various technologies
  • Participate in interpretation of results and authorship of final reports
  • Contribute to innovation of current and new assays workflows, technologies and processes
  • Participate in assay finalization and analytical validation of assay methods and processes
  • Support the best principles of Clinical Laboratory Improvement Amendments (CLIA), Good Laboratory and Clinical Practices (GLP/GCP) and design control in product development as appropriate (for example, requirements documents and design history files)
  • Participate in cross-functional process development and improvement teams working to improve efficiency, throughput, cost, and quality
  • Represent Engineering on cross-functional teams
  • Participate in cross-functional teams troubleshooting and resolving anomalies in laboratory processing

 

 

Requirements
  • Participate in evaluating commercially available laboratory instrumentation, robotics, and software for application at Genomic Health
  • Analyze workflows, identify bottlenecks, and make suggestions for process improvements
  • Other responsibilities as assigned

 

The ideal candidate will have prior, demonstrated experience designing, developing, testing, implementing, and supporting automated sample-processing workflows using a requirements-driven approach in a clinical laboratory or other molecular biology-based laboratory setting. He or she will also have experience leveraging an understanding of molecular biology, biochemistry, and histology techniques to troubleshoot analytical and preparative processes. The successful candidate will apply scientific methods and engineering skills to improve the scalability of Genomic Health’s sample processing workflows.

  • B.S. / M.S in molecular biology, genetics or biochemistry, bioengineering, chemical engineering or a closely-related discipline with a minimum of 5-8 years of relevant experience in an academic or commercial setting is required
  • Experience in streamlining workflows and developing automated laboratory processes and instrumentation systems, including collecting and documenting requirements, developing concepts, design, testing/validation, implementing, and training
  • Experience with operating a variety of liquid handling robotics platforms
  • Demonstrated ability to contribute effectively in cross-functional process development, improvement, and troubleshooting teams
  • Experience with standard molecular biology techniques such as nucleic acid isolation, purification and quantitation, bioanalyzer, DNA/RNA quantitation, qPCR or next generation sequencing PCR
  • Strong written and oral communication skills with a commitment to maintain open communication with internal employees, managers and customers as needed
  • Experience communicating and collaborating with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines
  • A track record of successfully completing complex assignments and meeting goals within aggressive timelines
  • Experience monitoring data quality and troubleshooting technical problems
  • Excellent organizational and planning skills
  • Proficiency in using basic word processing and spreadsheet applications
  • Able to integrate and apply feedback in a professional manner
  • Able to prioritize and drive to results with a strong commitment to quality

 

DESIRED

  • Basic working knowledge of statistics and statistical software tools (e.g. JMP, SAS etc)
  • Experience with using Laboratory Information Management Systems (LIMS)
  • Familiarity with histology laboratory processes
  • Experience programming a variety of liquid handling robotics platforms, as well as adapting and validating assays for robotics
  • Knowledge of TECAN EVOWare and/or Hamilton Venus scripting language is desirable
  • Demonstrated ability to lead small, cross-functional process improvement teams
  • Familiarity with change control, Six Sigma, Lean Manufacturing, Kaizen principles
  • Familiarity with optical instrumentation and digital imaging
  • Familiarity with digital pathology instrumentation and software
  • Familiarity with scheduling software for automated systems

 

 

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:

 

  • Travel Requirements:

Up to 10% Travel, domestic and international

  • Standing or sitting for long periods of time may be necessary
  • May occasionally lift and/or move up to 75 pounds
  • May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation
  • Repetitive manual pipetting may be necessary

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