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Senior Scientist, MDx - United States  

Company managed [?] Still accepting applications

Posted on : 20 June 2017

Project Description

Our Mission: 
Earlier insights can make all the difference
  • Within company Diagnostics we are committed to protecting the health of expectant mothers, babies, and families because through early diagnosis and treatment, there can be better outcomes for the families we serve. 
  •  For these reasons, we provide a complete portfolio of screening, diagnostic, medical imaging and treatment systems that go a long way toward ensuring a pro-active approach to healthcare.
  • We are focused on pioneering work in prenatal risk assessment and neonatal screening; delivering next-generation instrumentation and diagnostic capabilities; and providing cord-blood stem-cell banking services. 
  • Our advances in digital imaging technology address some of the most demanding X-ray applications to enable oncology, cardiovascular and neurovascular imaging systems. We are also bringing infectious disease diagnostics to expanded parts of the world delivering safety and peace of mind at affordable price points.
 

Purpose:
To provide hands-on contributions and technical and assay development direction to the molecular assay development team as well as acting as a liaison with other functions and external partners. This team is primarily responsible for developing PCR-based assays and integrating the assays into automated instrument platforms under an IVD quality system for Newborn Screening and adjacent clinical space.
 

Responsibilities:   
  • Assay development in compliance with applicable US and international Medical Device regulations and standards.   
    • Generate concepts and design new assays 
    • Perform assay optimization, troubleshooting, and transfer of technology to manufacturing 
    • Analyze, interpret, document and present experiment results 
    • Perform verification and validation studies 
    • Create and edit project documents within the IVD product development framework     
  • Technical evaluation of new technologies, assay development and project opportunities   
    • Maintain good understanding of relevant technologies/principles in own discipline and closely related areas and communicate knowledge obtained from external sources to the team     
  • Working with R&D and Business leaders, evaluate and scope new project opportunities   
    • Develop and maintain relationships with collaborators     
  • External communications   
    • Attend relevant conferences 
    • Author posters and give presentations     
  • Laboratory Maintenance and Compliance   
    • Maintain compliance with all company policies, quality systems, and procedures 
    • Participate with larger R&D team in instrument maintenance 
    • Work with Quality Manager to prepare for periodic internal and external quality audits     

 
Job Requirements : 
Education and Experience:   
  • PhD in Life Sciences or Masters in Life Sciences or Engineering with 3+ years of industry experiences in IVD assay development.  


Other Requirements:   
  • In-depth knowledge of nuclear acid chemistry and 2+ years of hands-on experience on nuclear acid sample preparation and real-time PCR. 
  • Ability to independently plan and execute complex experiments, identify problems and devise creative and workable solutions. 
  • Exhibits strong bias for action and results orientation. 
  • Knowledge of DFSS and ability to design, execute and analyze DOEs and do appropriate statistical analysis using statistical tools (JMP or Minilab) is highly desirable. 
  • A proactive attitude and the ability to work in fast-paced, collaborative environment. 
  • Excellent organizational, written, analytical, interpersonal and communication skills. 
  • A great team player, and able to multi-task effectively and be fully committed to product development timelines. 
  • Work well with others at all levels across a matrix organization demonstrating a collegial and productive manner.