Scientist III, IVD Product Development
Requisition ID: 121086BR
South San Francisco, CA
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?
The Genetic Sciences Division is seeking an experienced and highly motivated Development Scientist to work on a team developing qPCR based microbial detection applications for regulated markets. The candidate will have a strong understanding of regulated product development (CE-IVD or US IVD) and QSR systems, a broad understanding of molecular biology and/or biotechnology, strong writing skills, and the ability to collaborate effectively as part of a cross functional team including R&D, Software, Product Managers, Manufacturing and external partners
What will you do?
- Write protocols and reports required for development of regulated products
- Provide technical guidance during interactions with US FDA and other regulatory bodies
- Develop plans to ensure laboratories meet ISO 13485 regulations
- Transfer new qPCR products and processes to Manufacturing.
- Support product launch activities and perform on-market product and manufacturing troubleshooting with strong “customer-first” mind set
- Design experiments required for development and validation of products