R&D, Senior Staff Scientist, Consumable Assay Technology

at  Roche

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The Position
We advance science so that we all have more time with the people we love.
GenMark, a member of the Roche Group, is dedicated to providing world-class solutions for multiplex testing, with enhanced features that contribute to Roche’s commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the world’s #1 provider of companion diagnostics, the Roche Group offers an unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

As a member of our R&D team, the Senior Staff Scientist will define and execute multiple product improvements to meet customer needs, address internal needs such as manufacturing process improvements, and other product lifecycle scientific needs and may help develop next generation products. In addition, the Senior Staff Scientist will partner and lead closely with internal scientists, engineers and external partners to develop protocols for microfluidic consumable and assay development; will work cross-functionally to drive product, process, and tool improvements to ensure fact-based scientific, engineering, and analytical best practices and principles are utilized.

• You will maintain and advance the broad knowledge of principles, best practices and literature in molecular biology, assay integration, protein / enzyme analytical sciences and bioengineering / consumables functionality.
• You will manage, evaluate and approve complex design changes across multiple disciplines to ensure customer and internal requirements are met
• You will create partnerships with RA/QA to ensure compliance to applicable legal and regulatory standards and build collaborative partnerships with local GenMark staff and with global teams at Roche
• You will design, conduct and direct complex experiments and characterization studies for assay conditions and material variables, with consideration for critical to quality attributes
• You will design multifactorial experiments on and off cartridge and consumables to troubleshoot and resolve failure modes
• You will conceptualize and develop analytical methodologies to aid product characterization and process development, for critical parameter management
• You will optimize existing or develop new molecular diagnostics assays.
• You will lead Engineering Change Orders, such as BOM, SPECs, Manufacturing work instructions; you will be responsible for data processing, graphing, design of experiments (DOE), and statistical analysis (ANOVA)

Please refer the Job description for details