R&D, Scientist, Consumable Assay Technology

Company: F. Hoffmann-La Roche AG
Location: Carlsbad
Posted on: November 6, 2024

Job Description:

R&D, Scientist, Consumable Assay Technology
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
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 Scientist will support the scientific research and development strategies through a combination of research staff and individual studies. This individual will collaborate on a strategic approach to experimental design; will review and understand complex and interdisciplinary project objectives and will evaluate current technical data and specifications, and offer recommendations to meet objectives. This individual will support innovative and impactful experimental designs to drive research efficiency and effectiveness and maintain a high level of expertise through scientific literature, competitor products, and seminars.

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• You will evaluate current technical data and specifications, and offer recommendations to meet objectives.
  
• You will support and/or write formal study plans and study reports, including Technical Study Reports, etc.
  
• You will collaborate to identify, create and develop new methods to achieve technical objectives; you will integrate results with project and division objectives.
  
• You have expertise in infectious diseases and molecular biology techniques, including principles of nucleic acid hybridization, probe and primer design, molecular cloning and technologies for amplification of specific gene sequences.
  
• You will conduct data processing, create visualizations, design experiments (DOE), and perform statistical analysis (such as ANOVA) using tools like JMP, R, and others as needed.
  
• You may contribute toward or produce invention disclosures, patents and publications.
  
• You may guide or supervise the work of more junior technical staff including research associates on assay development projects.
  
  Who You Are:(Required)
  
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  • You have a BS in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry, Biomedical Engineering or a related field with 12+ years of experience as a scientist in the medical diagnostic or life sciences product development; or a Masters in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry, Biomedical Engineering or a related field with 10+ years of experience as a scientist in the medical diagnostic or life sciences product development; or a PhD in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry, Biomedical Engineering or a related field with 1+ years of experience as a scientist in the medical diagnostic or life sciences product development.
    
  • You have demonstrated experience supporting the development of complex products.
    
  • You have a solid (1-5) publication, patent and product portfolio.
    
  • You have demonstrated experience with the development of molecular diagnostics from product concept through FDA clearance including but not limited to: Initial development/feasibility activities, Transfer to Manufacturing, Verification and Validation studies.
    
  • You have a proven track record of IVD product development.
    
  • You have demonstrated experience in data analysis (including various statistical analyses and DOE), research design, and evaluation of new techniques & procedures for products, systems or technologies.
    
  • You have demonstrated problem solving, judgment and decision making skills; you have demonstrated ability mentoring junior engineers, research associates and/or others as needed.
    
    Preferred:
    
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    • You have experience with sample preparation of difficult matrices.
      
    • You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you have the ability to formulate and solve problems; you complete work in a timely, accurate and thorough manner.
      
    • You have the ability to think and work both tactically and strategically to provide financial and operational needs to GenMark's business.
      
    • You have effective analytical problem solving and decision-making skills.
      
    • You have experience leading and/or managing projects.
      
    • You have demonstrated experience establishing constructive working relationships, the ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.
      
    • You have a familiarity with relevant FDA guidance documents.
      
      WORK ENVIRONMENTThe essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
      This position is based in Carlsbad, CA.
      Relocation benefits are not available for this position.
      The expected salary range for this position based on the primary location of Carlsbad, CA is $87,500 - $162,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
      This position also qualifies for the benefits detailed at the link provided below.
      Who we are
      GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.
      GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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Keywords: F. Hoffmann-La Roche AG, Yorba Linda , R&D, Scientist, Consumable Assay Technology, IT / Software / Systems , Carlsbad, California