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Scientist 1 - Assay On Market Support and Development

Company: Illumina
Location: San Diego
Posted on: September 15, 2020

Job Description:

Scientist I - Assay On-Market Support and Development

As a Scientist within Illumina's Assay Development organization, you will work as part of a multi-disciplinary team to ensure clinical products meet their stated claims, continuously meet global regulatory standards, meet customers' expectations, and remain competitive in the markets they serve.

The foundation for this role is a deep understanding and hands-on experience with molecular biology. Experience in clinical diagnostics assays and assay/systems integration is desirable.

Tasks and Responsibilities


  • As part of the Assay On-Market Support and Development team, contribute to ongoing investigations, including elevated complaint investigations and CAPAs, and design changes for product improvements.
  • Design and execute experiments, keep detailed lab notebooks, perform data analysis, draw conclusions and define next steps, write reports and present results and updates to manager and teams as needed.
  • Plan and coordinate technical and cross-functional activities to move design changes, troubleshooting projects and investigations forward.
  • Collaborate with quality engineers, product marketing, assay development scientists, manufacturing, hardware engineers, and software engineers as needed in supporting scientific studies aimed at supporting products on the market.
  • Communicate results and conclusions to aid in team decision making in a fast-paced environment
  • Manage goals and duties within defined target timeframes

    Required Skills & Experience

    • Ph.D. in biochemistry, molecular biology, genetics, genomics, bioengineering or related field with minimum 0-3 years of experience or Bachelors/Masters in the same fields with 7+ years of experience.
    • Demonstrated laboratory and troubleshooting experience with clinical samples, sample preparation and PCR workflows and solid understanding of standard molecular biology techniques for DNA and RNA.
    • Ability to think and work independently as well as in a multidisciplinary team environment
    • Analytical, detail oriented, organized, efficient, problem solver with excellent verbal and written communication skills
    • Must have a desire to be part of a fast-paced, dynamic, cross-functional environment
    • Must be fluent in use of Microsoft Word, PowerPoint, and Excel

      Preferred Skills & Experience

      • Hands-on experience with next generation sequencing technologies (NGS). Experience with HiSeq, NextSeq or MiSeq operation is desirable
      • Experience with Illumina's sample prep methods strongly preferred
      • Experience with liquid handling robots (e.g. Tecan, Hamilton, Eppendorf) is desirable
      • Clinical experience such as: IVD product development, Laboratory Developed Tests (LDT), and/or Companion Diagnostics (CDx) desirable
      • Experience with design controls, risk management, change management, CAPA and failure investigation desirable.
      • Knowledge of NGS secondary analysis techniques, and data analysis software tools such as JMP or R desirable


        Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Keywords: Illumina, San Diego , Scientist 1 - Assay On Market Support and Development, Other , San Diego, California

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