When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 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.
Sr Staff Scientist IVD
This position will play a pivotal role within the Ion Torrent clinical product development. The unique individual selected for this position will have high visibility throughout the company. Responsibilities include interacting with cross-functional teams from R&D, operations, quality, and regulatory affairs. If you have experience in DNA sequencing and developing assays in the in vitro diagnostics industry, this could be a very exciting position for you.
- Will develop and validate an automated next generation IVD sequencing system based on Ion Torrent technology with the objective of meeting FDA regulatory requirements for commercialization.
- You will apply your management and laboratory skills and experience working in the regulatory environment for IVD product development, verification and validation, manufacturing and transfer, and commercialization.
- The ability to communicate with stakeholders, manage projects, meticulously document and communicate results to diverse audiences is important aspects of this role.
Minimum Qualifications (must have)
- MS or Ph.D. in molecular biology, chemistry or equivalent discipline.
- At least 10 years of experience in commercial assay development setting.
- Experience in IVD assay development including: reagent development and optimization, assay protocol optimization, verification and validation protocol writing and execution, conformance with IVD design control regulations.
- Proven experience in the development of quality control methods and specification setting.
- Solid knowledge and laboratory skills in nucleic acid analysis including PCR amplification and purification.
- Previous experience managing a technical team.
- Excellent organizational, record keeping and communication skills.
- A strong work ethic to generate high quality data under tight deadlines in a fast-pace environment, collaborative and proactive attitude a must.
Preferred Qualifications (nice to have)
- Experience in Next Generation Sequencing is a big plus.
At Thermo Fisher Scientific, each one of our 50,000 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
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.