Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific Information

Fremont, CA | Clinical Diagnostics Division

How will you make an impact?

The Staff Scientist position will be in R&D team leading the development of innovative IVD products. The position will utilize knowledge of new product development, clinical diagnostics, biochemistry and molecular biology to develop Quality Control products in In Vitro Diagnostic field.

What will you do?

* Clinical diagnostic quality control product development, including COVID-19 related products
* Lead project design, planning, execution and documentation
* Able to lead multiple projects in parallel
* Performs laboratory experiments such as sample testing on various platforms, preparation of reagents, and running immunoassays, qPCR assays, and cell culture
* This position requires 40% hands on in the laboratory and up to 60% of time for documentation
* Actively participates as a key member of cross-functional product development team

How will you get here?

* PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering with at least 5 years in IVD medical device field
* M.S. in Biochemistry, Microbiology, Molecular Biology, or equivalent, with minimum 7 years industry experience in IVD medical device field
* B.S. in Biochemistry, Microbiology, Molecular Biology, or equivalent, with minimum 12 years industry experience in IVD medical device field
* Industry experience in IVD medical device field
* Hands-on experience on nucleic acid-based assay development, reagent development, qPCR, molecular cloning, and cell culture
* Experienced with development and launching the IVD medical device, including writing verification/validation protocols and reports.

Knowledge, Skills, Abilities

* Knowledge and experience in clinical diagnostics IVD product development
* Must be highly collaborative; have the ability to work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community
* Self-motivated, independent, and a proactive driving force of execution
* Preferred to be trained in ISO 13485, 21 CFR Part 820 Quality Systems Regulation
* Familiar with regulatory requirements for US-IVD and CE-IVD
* Strong communication and presentation 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 missionenabling our customers to make the world healthier, cleaner and safer.

Apply today! 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.