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R&D Scientist II

3 months ago


Fremont, United States Varite Full time
Job Description:
R&D Scientist II
Exact Schedule - 8am-5pm M-F
Fully onsite

How will you make an impact?
Niche Diagnostics within the Clinical Diagnostics Division of *** Scientific 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. Plan day-to-day tasks without direct guidance.
  • 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.
  • Perform other responsibilities to support the needs of the department as assigned.
  • 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.
  • Self-motivated, independent and a proactive driving force of efficient execution.
  • Must be willing to take direction from a Senior Scientist/Project Technical Lead in the execution of lab studies.
  • Experience working with biological materials is preferred.
  • Strong verbal and written communication skills are required.
  • Ability to work constructively on a team is required.
  • Ability to use word processing, presentation and spreadsheet software is required.
  • Good organization and time management skills are 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.
•Patience and willingness to learn are a must.