Senior Scientist, Investigations, Support & Transfer (ISAT)

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The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

What if every day you could wake up, excited to come to work, knowing YOU can impact the the future for a patient waiting for a life-changing/saving treatment? At GenMark/Roche we are grateful to work with amazing colleagues to pursue that mission. We are passionate about the science, embracing creativity, agility and quality in all we do. We pride ourselves on an inclusive atmosphere where diverse ideas, backgrounds and viewpoints are valued. AND we have fun doing it!

As a Senior Scientist, Investigations, Support & Transfer (ISAT), you will be responsible for representing cobas® eplex assay manufacturing science and technology (MSAT) to lead and support cross-functional teams to design, develop and transfer of new molecular diagnostic products to commercial production.  Drawing on diverse knowledge and skill in molecular assay technology, manufacturing processes, investigation, and molecular device regulations, this individual will lead technical transfer of products and processes within the global manufacturing network or to OEM partners, identify and implement product and process improvements, and serve as subject matter expert on cobas eplex design and process. You will have an opporutnity to lead and participat in projects to troubleshoot, improve process efficiency and yield, and maintain quality and compliance within manufacturing operations for on market products is also a key role for this position. 

The Opportunity

• Represent and provide guidance to new product core teams on the following function areas: assay manufacturing science and technology (MSAT), Manufacturing Technical Operations (MTO), Manufacturing Operations, Supply Chain, Quality Control, Training and Facilities.

• Participate in cross-functional development and transfer teams to advise, plan, coordinate operations-related transfer activities. Communicate progress and escalate issues identified in sub-teams up to core teams for discussion and decisions. Ensure smooth introduction and ongoing support of new products into manufacturing.

• Coordinate and manage tasks related to on-time delivery of transfer phase deliverables including creation of formulations and manufacturing work instructions, quality documents, specifications in-process test and release QC methods, and verification/validation protocols and reports.

• Provide effective feedback on product reliability investigations to incorporate “Lessons Learned” into the upstream development pipeline.

• Perform structured root cause investigation of cobas eplex product and process issues and implement corrective and preventive measures.  

• Provide Scientific Technical support for multiple functions including, manufacturing, QA, QC, Regulatory, R&D, Customer Support, Supply Chain, among others.

Who You Are

• A Bachelors or Masters degree in Science (e.g. Biological Science, Biomedical or Chemical Engineering) Required. PhD preferred.

• 5+ years of experience in an Operations setting in a Biotechnology, Medical Device or Pharmaceutical manufacturing environment.

• Extensive experience of Diagnostic reagent manufacturing processes, technical transfers, investigation management and data analytics

• Extensive experience with validation of manufacturing equipment, clean utility and process systems, including requirements for documentation and testing.

• Knowledge of Roche internal and external quality and regulatory requirements

• Proven experience in consensus building and conflict management in challenging or difficult situations.

Skills – Technical 

• Experience with technologies present in cobas® eplex manufacturing process and assay design such as micro volume dispensing, coating, electrowetting, nucleic acid extraction, multiplex PCR, electro chemical detection, and digital signal processing.

• Advanced experience with root cause analysis, design of experiments, data analysis, and process risk analyses .

• Experience with qualification, verification, and validation requirements as related to parts, equipment