Manager, Development

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

    Job Title: Manager Development
    Requisition ID: 135635BR

    When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

    Location/Division Specific Information
    South San Francisco, CA/ Genetic Sciences Division

    How will you make an impact?
    The Genetic Testing Solutions group is a team of passionate individuals who are deeply committed to making the world healthier through development of molecular assays. This role will be responsible for leading a team to develop and commercialize products for both research and clinical applications on Thermo Fisher Scientific sample-to-answer platforms. This is an opportunity for a highly motivated IVD leader to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine.
    What will you do?
    • Actively participates as a member of cross-functional IVD and RUO development teams.
    • Manages postlaunch development activities including design changes and DHF updates.
    • Manages global internal and external partnerships to complete development studies.
    • Ensures projects meet timelines; identifies and removes roadblocks to team success.
    • Leads high quality science and data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods.
    • Ensures DHFs and technical files meet applicable standards. Documentation under design control to ensure quality product development.
    • Drives continuous process improvement.
    How will you get here?

    PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering with min 5 yrs of experience in medical device / IVD industry

    • Highly skilled in managing diverse resources across different functions, businesses and time zones
    • Strong project management experience, leading highly collaborative teams and nurturing an innovative, positive work environment
    • Extremely clear communicator who sets unambiguous goals and clear priorities
    • Strong experience in IVD product development, following ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971
    • Demonstrated teamwork under tight timelines
    • Have launched 510k/PMA and / or List A CE-IVDD (or List D IVDR)
    • Design Control & Change control, and experience writing design quality records
    Knowledge, Skills, Abilities
    • Expertise in Process Capability / Six Sigma.
    • Experience participating in audits.
    • Demonstrates passion for problem solving and outside-the-box thinking.
    • Self-motivated, independent, proactive, organized, diligent, and very nimble.
    At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

    Apply today!

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

    Posting ID: 588108873Posted: 2020-11-19