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Senior Automation Scientist 9/3/2016

Genomic Health Redwood City, CA

Company
Genomic Health
Job Classification
Full Time
Company Ref #
2016-4727
AJE Ref #
576081455
Location
Redwood City, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
OVERVIEW:

The Senior Automation Engineer will be directly responsible for leading the development, scale up, and improvement of automated workflows used for and in support of existing and new diagnostic tests used in our state of the art Clinical Laboratory that utilize tissue and fluid based assays. He or she will participate in all aspects of assay automation development from concept, requirements definition, and manual assay development to adaptation, optimization, troubleshooting and validation of assays on an automated platform. Assay automation will include specification, characterization, integration, and implementation of robotic platforms and analytical instruments in both the Research & Development and Clinical Genomic Health laboratories. He or she will ensure that these laboratory processes are highly robust, scalable and meet stringent functional performance standards.

The Senior Automation Engineer will participate in or lead cross functional teams working in a variety of projects. These include collaborating with diverse disciplines including, research and development, process engineering, reagent quality, software development, biostatistics, data management, clinical 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. He or she will be expected, after training, to perform all laboratory procedures needed to process samples with our workflows to support process development and implementation activities. He or she will also be expected to lead cross functional teams to design, execute, and interpret experimental studies. The Senior Automation Engineer will also be responsible for contributing to protocol generation, report writing and presentation preparation.

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 leverage 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.

RESPONSIBILITIES:

* Lead or contribute to the design, develop, optimize, test, and implement automated processes, systems, and streamlined workflows for the clinical 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

* Lead or contribute to design and execute experiments in a timely manner with well-organized and documented analysis

* Drive collection of process requirements from cross-functional stakeholders

* Coordinate and/or conduct training in the proper use of GHI instrumentation and processes

* Provide troubleshooting support for Service Engineering and our Clinical and Research & Development laboratories

* 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

* Lead or 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)

* Lead or contribute to 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

* 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

QUALIFICATIONS:

REQUIRED

* A BS degree in engineering or science, preferably in molecular biology, genetics or biochemistry, bioengineering, chemical engineering or a closely-related discipline and a minimum of 10 years of related experience. An MS with 8+ years of related work experience or a PhD with 5+ years of related work experience will also be considered.

* 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 and lead 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

* Experience with 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

* Familiarity with change control, Six Sigma, Lean Manufacturing, Kaizen principles

* Familiarity with optical instrumentation and digital imaging

* Familiarity with digital