Scientist III, IVD Studies and Submissions

    Thermo Fisher Scientific Inc.
    South San Francisco, CA 94080
    Full-time
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    Job Description

    Scientist III, IVD Studies and Submissions
    Requisition ID:126801BR

    Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. This key role will play a valuable part in our efforts.

    Do you have a passion for innovative ideas and groundbreaking discoveries? Now is an exciting time to join our Genetic Sciences business. With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

    US - South San Francisco, CA
    Genetic Testing Solutions: IVD Studies and Submissions team

    How will you make an impact?
    The Genetic Testing Solutions group is seeking an experienced and highly motivated Scientist to work on a team to support analytical validation studies and submissions for qPCR based microbial detection products for the regulated markets. The candidate will have strong writing skills, strong understanding of regulated product development process (CE-IVD or US IVD) and QSR systems, a broad understanding of molecular biology and/or biotechnology, and the ability to collaborate effectively as part of a cross functional team including R&D, Regulatory, Quality, Software, Product Management, Manufacturing and external partners

    What will you do?
    • Design analytical performance studies required for regulated products
    • Drive planning and execution of development and validation studies by R&D personnel
    • Write performance evaluation protocols and reports in compliance with CLSI standards, and regulatory requirements
    • Serve as IVD product development subject matter expert on project Core Teams
    • Provide technical guidance during interactions with US FDA and other regulatory bodies
    • Support product launch activities with strong "customer-first" mindset
    How will you get here?
    Education

    BA/BS Degree, 5+ years/ MS Degree, 3+ years/ PhD Degree, 2+ years of industry experience

    Experience
    • Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
    • Background in molecular biology (including DNA, RNA and protein handling, PCR, qPCR, quantification methods)
    • Understanding of Quality Systems Regulations and IVD product development
    • Knowledge of data analysis software(s), such as JMP, is preferred
    Knowledge, Skills, Abilities
    • Driven to deliver quality results on time and in a highly ethical and professional manner
    • Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective
    • Must be tolerant to change, ready to take on new challenges and open to learning new skills
    Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

    *EVRD2020 *GTSDouble

    Posting ID: 588108732Posted: 2020-11-19