Job Description: The Genetic Sequencing 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

Job Description Details

• 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
• Support technical transfer, 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
• Supervise team members when necessary

Education/Experience/Skills:

• Staff Scientist: BA/BS Degree, 7+ years/ MS Degree, 5+ years/ PhD Degree, 3+ years of industry experience
• Strong skills in molecular biology (including DNA, RNA and protein handling, PCR, qPCR, quantification methods)
• Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
• Understanding of Quality Systems Regulations and cGMP product development
• Knowledge of data analysis and proficient in use of JMP software is preferred
• Driven to deliver quality results on time and in a highly ethical and professional manner
• Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective
• Must be tolerant to change, ready to take on new challenges and open to learning new skills

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer. At Thermo Fisher Scientific, each one of our 75,000 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