Myriad Genetics, Inc.

  • Associate Scientist I

    Location US-UT-Salt Lake City
    Posted Date 1 month ago(12/14/2018 8:08 AM)
    Job ID
    2018-7760
    Location Details
    Salt Lake
    Name
    Myriad Oncology
  • Overview

    The  Quality Assurance & Regulatory Affairs team of Myriad Genetic Laboratories is seeking a full-time Associate Scientist to work on molecular diagnostic tests regulated by the FDA, CLIA, CAP and NYSDOH.  Current projects include IDE and PMA submissions for companion diagnostic (CDx) tests.

    Responsibilities

    The responsibilities will include:

    1. Contributing to FDA PMA, 510(k),and IDE submissions.
    2. Support NYSDOH, CLIA/CAP and other assigned regulatory submissions.
    3. Ensuring Quality System Regulations (QSR), ISO (e.g. 13485), CLIA/CAP and NYSDOH compliance for molecular diagnostic testing.
    4. Defining, writing up and planning/leading/performing feasibility, development, verification and validation studies.
    5. Support Regulatory Affairs and Quality Assurance teams.
    6. Support development and production teams/laboratories.
    7. Participate in device and process improvements as needed.
    8. Cross-functional collaboration and coordination with program/project managers and relevant teams and stakeholders to meet defined deliverables and timelines.
    9. Other related duties as needed.

    Qualifications

    • Ph.D. or related degree in life sciences with a minimum of 1 year of clinical molecular diagnostics experience; or
    • M.Sc. in life sciences with a minimum of 2 years of clinical molecular diagnostics experience; or
    • B.Sc. in life sciences with a minimum of 3 years of clinical molecular diagnostics experience.

     

    • Work experience in regulated products; for example, FDA approved In Vitro Diagnostic devices, PMA or 510(k) submissions, QSR and Design Control, and CLIA/CAP and NYSDOH compliance, especially in verifications and validations.
    • Strong scientific expertise and knowledge base in nucleic acid testing.
    • Excellent written and oral communication skills.
    • Proven ability for cross-functional work and meeting project timelines.
    • The ability to work independently and function as a leader is highly desired.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.

    About Our Company

    Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

     

    Myriad is an equal opportunity employer and as such, affirms in policy and practice to recruit, hire, train and promote, in all job classifications without regard to race, color, religion, gender, age, sexual orientation, gender identity, national origin, disability status or status as a protected veteran.

     

    Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures. We believe that diversity lends a regional, national, and global advantage to the clients we serve. Our workforce consists of dynamic individuals, with a range of backgrounds, talents, and skills.

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