Thermo Fisher Scientific Sci III, Development in South San Francisco, California
How will you make an impact?
The Genetic Testing Solutions group is a team of passionate individuals who are deeply committed to making the world healthier through development of molecular assays. This role will be part of team developing products for both research and clinical applications on Thermo Fisher Scientific sample-to-answer platforms.
This is an opportunity for a highly motivated IVD scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine. The successful candidate will incorporate IVD and molecular biology experience to develop robust and innovative diagnostics that make an impact on world health. This position will be an integral part of advancing genetic analysis in the clinical market.
Job responsibilities include:
Participates in IVD development, from proof of concept to validation, regulatory submission and launch
This is a hands on bench scientist position that involves both proof of concept testing and rigorous validation
Collaborates across functions, eg. software, product mgmt., QARA etc.
Ensures products are adequately developed to enable smooth Design Transfer
Actively participates as a member of cross-functional product development teams
Performs high quality science and data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods
Ensures DHFs and technical files meet applicable standards. Documentation under design control to ensure quality product development.
Drives continuous process improvement
Ensures projects meet timelines; identifies and removes roadblocks to team success
How will you get there? Experience required:
PhD or higher in Molecular Biology / Genetics / Biochemistry / Bioengineering and minimum 1 year experience in biotech
Demonstrated teamwork under tight timelines. Is extremely organized and driven to complete projects efficiently.
Commercial qPCR assay development experience
Strong experience working in a regulated environment OR demonstrated attention to detail.
Expertise in Process Capability / Six Sigma using JMP analysis
Demonstrates passion for problem solving and outside-the-box thinking
Strong written communication and verbal presentation skills are essential
Must be highly collaborative; enjoys working in a diverse team and contributes to a positive work environment
Experience in Design Control and IVD development preferred
Self-motivated, independent, proactive, organized, diligent, and very nimble *EVRD2020 *GTSDouble
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.