Job Description

Thermo202FFisher is at the forefront of the global response to202FCOVID-19. We are working with governments, 202Fagencies, industry partners and researchers202Fglobally to ensure priority access to instruments, 202Fconsumables, safety supplies and other products202Fto address the outbreak. This key role will play a valuable part in our efforts.

Do you have a passion for innovative ideas and groundbreaking discoveries? Now is an exciting time to join our Genetic Sciences business. With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you2019ll help solve some of the world2019s toughest challenges. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

US - South San Francisco, CA

Genetic Testing Solutions: Assay and Product Development team

How will you make an impact?

The Genetic Testing Solutions group 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 201Ccustomer-first201D mind set
* Design experiments required for development and validation of products

How will you get here?

Education

BA/BS Degree, 7+ years/ MS Degree, 5+ years/ PhD Degree, 2+ years of industry experience

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 software(s), including JMP, is preferred

Knowledge, Skills, Abilities

* 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

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

*EVRD2020 *GTSDouble