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Thermo Fisher Scientific Staff Scientist / Lead, IVD Study Design in Carlsbad, California

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

  • Potential to supervise 1 - 3 employees as group expands

How will you get here?

Education

BA/BS Degree, 10+ years/ MS Degree, 8+ years/ PhD Degree, 3 - 5+ 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

  • Management experience is a plus

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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