The Clinical Diagnostics Division of Thermo Fisher Scientific is seeking a highly motivated, innovative and experienced professional to join the Research and Development department based in Fremont, California. This position will be part of the product development team responsible for developing liquid chromatography – tandem mass spectrometry (LC-MSMS) based clinical assays and reagents in a FDA/ISO regulated environment.
- Develop and validate sample preparation and LC-MSMS quantification methods for analysis of small molecules in biological matrixes.
- Develop and manufacture assay reagents using biological matrices (for e.g. human serum, human whole blood) such as calibrators and controls as per FDA GMP procedures
- Operate and maintain lab equipment including executing daily, weekly and monthly maintenance of LCMS instruments. Participate in troubleshooting of instrument and application issues.
- Comply with FDA /ISO requirements including Quality Systems Requirements
- Work cross-functionally to test and validate assay performance under clinical settings including preparing human clinical sample sets for specific studies
- Work cross-functionally to successfully transfer assay reagents to manufacturing
- Perform other responsibilities to support the needs of the department as assigned.
Job Requirements and Qualifications:
- Bachelors’ degree in a scientific or technical field with 2+ years of experience
- Hands on experience with quantitative bio-analytical samples and reagents preparation.
- Preference given to candidates with experience in operation and maintenance of LC-MS instruments and applications
- Preference given to candidates with experience working in a FDA GMP/ISO laboratory including writing and following SOPs and Work Instructions
- Strong communication and inter-personal skills including ability to work collaboratively in a global team
- Excellent time-management, planning and organization skills to handle and efficiently manage high workload and meet project timelines.
- Strong working knowledge of Windows based applications, internet technology, and scientific software.
This position is not approved for relocation benefits.
At Thermo Fisher Scientific, each one of our 55,000 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.
Join our Talent Community
If you're ready to make a difference in the world, you can do it here.Join