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 scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine. The successful candidate will be responsible for planning and management of sample test materials for new product development projects. This role will also develop robust and reliable incoming QC test methods for these materials to enable their use in critical IVD development projects. As such this position will be an integral part of advancing genetic analysis in the clinical market.
Job responsibilities include:
- Assesses new product development project needs for clinical samples and controls, and aligns procurement efforts to meet these needs
- Manages project samples and metadata following GLP
- Manages robust QC method development on incoming materials
- Participates in IVD development, from proof of concept to validation, regulatory submission and launch
- This is a hands on bench scientist position
- 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 documentation meets all applicable standards
- Drives continuous process improvement; provides innovative solutions to streamlining processes
- Ensures projects meet timelines; identifies and removes roadblocks to team success