Lead Scientist, IVD Study Design (Remote)

Lead Scientist, IVD Study Design (Remote)
Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments,  agencies, industry partners and researchers globally to ensure priority access to instruments,  consumables, safety supplies and other products to 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 you’ll help solve some of the world’s 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.

Genetic Testing Solutions: IVD Studies and Submissions team (Remote)

How will you make an impact?
The Genetic Testing Solutions group is seeking an experienced and highly motivated Scientist to work on a team that supports regulatory submissions for molecular diagnostics. The ideal candidate is experienced in IVD product development and is looking to transition out of the lab and into a position designing and supervising studies in support of regulatory submissions. This position offers a unique opportunity to contribute to all phases of product lifecycle, from feasibility through post-market support for a variety of molecular technologies. The candidate will have strong writing skills, understanding of the regulated product development process (CE-IVD or FDA) understanding of molecular biology and/or biotechnology and the ability to collaborate effectively as part of a cross-functional team including R&D, Regulatory, Quality, Software, Product Management and external partners. The position has the option of being 100% Remote.

What will you do?

• Design studies required for regulated products in close collaboration with Regulatory Affairs, R&D and Biostatisticians
• Serve as IVD product development representative and subject matter expert on project Core Teams
• Drive planning and execution of development and validation studies by R&D personnel
• Write protocols and reports in compliance with CLSI standards and regulatory requirements
• Provide technical guidance during interactions with US FDA and other regulatory bodies

• Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
• Background in molecular biology (including DNA, RNA and protein handling, PCR, qPCR, quantification methods)
• Understanding of Quality Systems Regulations and IVD product development

• 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
• Able to thrive in a fast-paced work environment
• Must be tolerant to change, ready to take on new challenges and open to learning new skills
• Management experience is a plus

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.
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