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Company: Microbiologics Inc
Location: Saint Cloud
Posted on: September 12, 2022

Job Description:

Microbiologics, a leader in providing external controls for molecular diagnostic assays is seeking to expand its Product Development Team with the addition of an experienced bench Scientist trained in molecular biology and assay diagnostics. The Scientist will be responsible for the design and development of real time PCR and RT-PCR IVD assay-based quality controls in an FDA-QSR and ISO13485 compliant organization. The ideal candidate will have experience in product commercialization, expert knowledge of concepts (such as nucleic acid extraction, real time PCR and Digital PCR), and a high level of scientific creativity and technical proficiency.The candidate will:

  • Utilize technology to lead development of innovative processes for creating quality controls for a wide array of in vitro diagnostic assays on the market especially around infectious disease testing.
  • Perform analytical studies required to demonstrate technical feasibility of quality control material for complex assays, develop/implement verification studies (LoD, LOQ, FMEA, Reproducibility), analyze data using statistical tools and author technical reports.
  • Coach Research Associates and drive their technical development under supervision of the Product Development Manager.
  • Write and review new SOPs as well as update existing department SOPs, as necessary.
  • Ensure proper care in the use and maintenance of equipment and supplies; promotes continuous improvement of workplace safety and environmental practices.The essential requirements of the job include:
    • Master's degree in related field with 4+ years of related work experience OR Doctoral degree in related field with 0-2 years of related work experience.
    • Flexibility to work independently and with research associates to solve complex problems, optimization of multiplex control materials, create new controls/methods/testing procedures.
    • Ability to design primer plus probes, perform multiplexed real-time PCR, ddPCR optimization experiments using DOE (Design of Experiment) and validate assays.
    • Ability to perform gene cloning and expression.
    • Experience with IVD product development and design controls in a GMP environment.
    • Strong problem-solving/troubleshooting skills and ability to drive consensus with data.
    • Ability to work in a laboratory and with BSL-2 organisms.
    • Experience with statistical analysis techniques and tools e.g., Minitab.
    • Organized self-starter with excellent problem solving and analytical skills.
      • A preferred candidate would have: *
        • Experience in developing molecular diagnostic assays/quality control products for clinical laboratory platforms like the Gene Xpert, BD Onclarity, BioFire Torch, Roche COBAS.
        • Proven track record of collaborating with cross functional teams to support development and transfer activities (R&D, Production, Regulatory and Quality).
        • Knowledge of analytical test methods based CLSI & FDA guidelinesJob Type: Full-time

Keywords: Microbiologics Inc, Saint Cloud , Scientist, Other , Saint Cloud, Minnesota

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