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    Regulatory Scientist - Kansas City, MO, United States - MRIGlobal

    MRIGlobal
    MRIGlobal Kansas City, MO, United States

    3 weeks ago

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    Description
    MRIGlobal solves challenging problems through science, engineering, and program management. We are an independent scientific research organization dedicated to benefiting society and fostering a safe, healthy, and sustainable environment.

    When you embark on a career with MRIGlobal, you are joining a crew of world-class talent and problem solvers. Principal Scientist – Integrated Health Surveillance & Diagnostics

    Founded in 1944, MRIGlobal is an independent, not-for-profit organization that performs contract research and other services for clients in business, industry and government.

    We currently have an opening for a Principal Scientist in our Cross-Functional Science team, part of the Integrated Health Surveillance & Diagnostics division, which is available immediately and located in Kansas City, MO.

    This Principal Scientist will join a team of researchers involved in research and development work in infectious disease diagnostics, biosurveillance, microbiology, virology, and microbial forensics for a variety of government and commercial clients.

    We are searching for candidates with a profound passion for applied research and the drive to craft robust and groundbreaking solutions for real-world challenges.

    Our ideal candidate is recognized as an expert in their field with a comprehensive understanding of unmet needs.

    In this role, you will drive the scientific and technical direction of initiatives that may involve multiple divisions and subcontractors.

    Additionally, this role offers an exciting opportunity to engage in internal research and development initiatives, where you can contribute to our quest for innovative solutions that shape the future.

    Your leadership and training will inspire a collaborative atmosphere where teamwork thrives, and your expertise will be a driving force behind transformative solutions.

    Examples of research activities may include one or more of the following efforts:

    Design, develop and validate clinical infectious disease diagnostic assays to support FDA EUA, PMA or 510(k) premarket notification, primarily focusing on molecular diagnostics and immunoassays.

    antimicrobial resistance or emerging infectious diseases), primarily using molecular, immunological, microbiological and/or biochemical strategies.

    Develop and validate innovative molecular, immunological and/or biochemical strategies to detect biothreat agents in challenging matrices for biosurveillance or microbial forensic applications.

    We aim to attract new talent into MRIGlobal's existing pool of forward-thinking research scientists focused on applied research in biomarkers of disease including infectious disease clinical diagnostics, environmental biosurveillance and microbial forensics.

    S.

    plus 12 years relevant experience, and expertise in molecular biology, microbiology, virology, immunology and/or biochemistry (or related field) is required, as described below:

    Evidence of scientific and technical leadership, as shown by proven track record as a Principal Investigator, Subject Matter Expert and/or Project Leader combined with publications and/or presentations at scientific meetings
    Expertise in diagnostics platform development (e.g., verification and validation testing)
    In vitro molecular techniques, especially experience with PCR, RT-PCR, assay/primer design experience, next generation sequencing and genomics and/or CRISPR
    Well organized and systematic, yet flexible in adjusting priorities, and able to take risks to accomplish goals.
    Proficient PC skills and ability to learn new software and systems.

    Experience in medical device development under 21 CFR 820 and/or ISO 13485; including knowledge of Design Controls, Quality Management Systems, and Risk Management for regulated products
    Basic understanding of the contract research business, federal regulations, proposal writing, and project management.
    Feel great with virtual coaching, no-cost counseling, onsite screenings, and chair massages (HQ). MRIGlobal offers award-winning employer retirement matches and no-cost financial education benefits. Enjoy PTO and a flexible culture that encourages work-life integration.

    At MRIGlobal, you will enjoy diverse work that will grow your skills set, along with a tuition reimbursement option to pay for higher education.


    A Genuine Community:
    EOE, including disability/vets. As an organization dedicated to scientific advancement, MRIGlobalinvites and embraces diversity in our people.

    Weare committedto creatinga safe, welcoming, and inclusive environment where everyone feels respected and represented,fostering a culture where all input is welcome.

    Weadapt to change, challenge the status quo, and evolve throughbelonging,allyship,and mutual support.
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