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Scientist

1 month ago

Fremont, United States Integration International Inc. Full time

Exact Schedule - 8am-5pm M-F

Fully onsite


How will you make an impact?

  • Niche Diagnostics within the Clinical Diagnostics Division of company is seeking a highly motivated, innovative and experienced professional to join the Research and Development department at Fremont, California.
  • This is a hands-on bench scientist position. Responsible for research and development to support the creation of new in-vitro diagnostics (IVD) immunoassay products. The ideal candidate shall have excellent hands-on lab skills, strong documentation skills, demonstrated ability to analyze and interpret data to draw conclusions and make recommendations, and strong collaboration and teamwork skills.


What will you do?

  • Contribute to the development of new immunoassay products for drug of abuse testing.
  • Screen antibodies for performance in new immunoassay products. May work with Senior scientist in the production of new antibodies.
  • Contribute to the design of new immunoassay products, conducting experiments under the guidance of more senior scientists.
  • Create test protocols and execute the benchtop testing in the lab against those protocols.
  • Formulate and optimize reagents for clinical analyzer testing, maintaining meticulous records in your lab notebook.
  • Review experimental results to confirm data accuracy, perform data analysis and make recommendations based on those results.
  • Perform all work in compliance with FDA Design Control guidance, ISO standards, cGMP, and other applicable regulations in the performance of your responsibilities.
  • Maintain a constant focus on safety in the lab and within the site.
  • Demonstrate a strong continuous improvement focus and execution of improvement projects.


How will you get here?

  • Bachelor in Biochemistry, Molecular Biology, Immunology, Microbiology or other related life science discipline with a minimum of 2 years of IVD product development experience. Or, M.S. or a Ph.D. in Biochemistry, Molecular Biology/related discipline with a minimum of 1 year of experience.
  • Hands-on lab skills and experience is required with a strong desire to work in the lab.
  • Experience working with biological materials is preferred.
  • Ability to use word processing, presentation and spreadsheet software is required.
  • Strong preference will be given to those candidates having hands-on lab-based experience in IVD assay development from concept through development to commercialization.
  • Knowledge and hands-on experience with immunoassay techniques and antibody-based technology is preferred.
  • Knowledge of FDA/ISO design control and regulatory requirements related to IVD products is preferred.