Thermo Fisher Scientific R & D Scientist II in Fremont, California

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

Niche Diagnostics within the Clinical Diagnostics Division of Thermo Fisher Scientific is seeking a highly motivated and innovative bench scientist to join the Research and Development department at Fremont, California as a Scientist II. The R&D Scientist II has demonstrated the ability to do bench-work in the lab with technical rigor, organization, and also has the ability to execute complex testing and provide interpretation of those results. This role is a key member of the team that will develop new immunoassays and associated documentation to deliver novel clinical testing products to the IVD (In-vitro diagnostics) market.

What will you do?

  • Perform assay development and test method validation per CLSI and FDA testing guidelines.

  • Design and execute experiments to optimize immunoassays and conduct experiment on automated clinical analyzers using clinical samples such as urine, saliva and blood etc.

  • Contribute to the design, formulation and characterization of new assay reagents including calibrators and controls.

  • Contribute to setting product specifications and specifying the raw materials for manufacturing and design transfer.

  • Perform technical testing, data collection, data analysis/interpretation and make recommendations for next steps. Execute complex experiments and perform statistical analysis, interpretation of experimental results using scientifically sound conclusions.

  • Write testing protocols and reports, manufacturing procedures, SOPs, and create data analysis workbooks, in-process and release specification sheets and other technical documents needed for the production and launch of new diagnostic products.

  • Comply with FDA Design Control guidance ISO standards, cGMP, and other applicable regulations in the performance of your responsibilities.

  • Collaborate with multidisciplinary functions to develop, manufacture and market quality IVD products meeting user requirements.

  • Work on a global multi-cultural cross-functional team to provide top quality results consistently and against project timelines.

  • Perform other responsibilities to support the needs of the department as assigned.

How will you get here?

  • Bachelor in Biochemistry, Molecular Biology, Analytical chemistry or other related life science discipline with a minimum of 2 years of professional work experience. Or, M.S. or a Ph.D. in Biochemistry, Molecular Biology/related discipline with a minimum of 1 year of experience.

  • Strong preference will be given to those candidates having hands-on laboratory-based experience in IVD assay development from concept through commercialization.

  • Knowledge and hands-on experience in homogeneous assay development is required. Strong interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment.

  • Excellent organization and strong project management skills

  • Must be able to work under pressure and coordinate numerous activities with a multi-disciplinary team of scientists

  • Knowledge of FDA/ISO design control and regulatory requirements related to IVD products.

  • Strong verbal and written communication skills.

  • Good work ethics, organization and strong project management skills.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com at http://jobs.thermofisher.com/

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.