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Sr. Staff Scientist, IVD Assay Development

Organization
Thermo Fisher Scientific
Job Location
180 Oyster POint Blvd.
South San Francisco, CA 94080
United States
Job Description

How will you make an impact?
The R&D Scientist - Infectious Disease (Clinical Vertical), will have leadership responsibility in planning and executing for scientific activities in the research and development of in clinically oriented products. Housed within the Genetic Sciences Division of Thermo Fisher Scientific, the successful candidate will lead microbial applications R&D projects and work collaboratively with product management, bioinformatics, manufacturing, and other R&D teams to take new assay products and applications through concept, feasibility, development, and commercialization. In addition, the candidate will actively participate in external communication and collaborations with thought leaders in microbiome and infectious disease research & diagnostics. This position will ensure that all projects are aligned to the needs of the customers and business, and that developmental timelines are met. In this position, you will drive results through inspired leadership and a focused and disciplined approach to product development that is consistent with best practices in the Company and in the industry as well as in compliance with appropriate regulatory requirements. This position will act as a resident expert for assays in development.

What will you do?

  • Manage research and development activities through all phases of product development
  • Interact cross-functionally to define products, transfer new designs to manufacturing, and ensure on-time regulatory submissions
  • Set clear product development timelines and prioritize efforts to deliver on commitments
  • Train and teach staff in areas of expertise
  • Identify and facilitate academic collaborations and interactions with opinion leaders that are aligned with company goals
  • Lead strategic road mapping efforts by linking potential customer requirements with R&D and product development initiatives
  • Work in the lab, design and execute studies, and perform troubleshooting
Requirements

Education
Masters or PhD in biology, biochemistry, molecular biology; related discipline or equivalent preferred.

Experience

  • 10+ years industry experience
  • 5+ years’ experience in molecular diagnostic assay development (Could be in LDT, CE-IVD or IVD space)
  • Expert and hands-on experience in diagnostic molecular methods with expertise in technologies including qPCR, Sanger sequencing and fragment analysis.
  • Familiarity with diagnostic methods for infectious diseases
  • Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
  • Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics


Knowledge, Skills, Abilities

  • Demonstrated ability to deliver results
  • Experience in a technical leadership role in diagnostics research and development
  • Demonstrated ability to build and foster relationships with scientific and medical thought leaders.
  • Experience in the process of product development and demonstrated track record for product development
  • Understanding of Quality Systems Regulations and cGMP product development
  • Driven to deliver quality results on time and in a highly ethical and professional manner
  • Demonstrated resourcefulness, strategic and analytical thinking, directed toward achieving objectives
  • Demonstrated self-motivation, problem solving ability, organizational skills, thoughtful and detail-oriented quality
About Our Organization

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.