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Scientist III, IVD Study Design

Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: July 14, 2021

Job Description:

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

How will you get here?

Education

BA/BS Degree, 5+ years/ MS Degree, 3+ years/ PhD Degree, 2+ years of industry experience

Experience

· 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

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

· 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

*EVRD2020 *GTSDouble

Keywords: Thermo Fisher Scientific, South San Francisco , Scientist III, IVD Study Design, Other , South San Francisco, California

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