Staff Scientist, IVD Assay Development
Employment Type: Full-Time
Staff Scientist, IVD Assay Development
Requisition ID: 121084BR
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.
US - South San Francisco, CA
Genetic Sciences Division
You 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. You will collaborate and communicate with thought leaders in microbiome and infectious disease research & diagnostics.
What will you do?
* Execute 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
* Work in the lab, design and execute studies, and perform troubleshooting
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.
How will you get here?
BS/MS/PhD in Biological Sciences or related discipline with industry or post-graduate experience (PhD with 5+ yrs/MS with 8-10 yrs/ BS with 10-15 yrs)
* 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.
* Experience in the process of product development and demonstrated track record for product development
Knowledge, Skills, Abilities
* Familiarity with diagnostic methods for infectious diseases
* Demonstrated ability to deliver results
* Self-motivation, problem solving ability, organizational skills, thoughtful and detail-oriented
* Demonstrated ability to build and foster relationships with scientific and medical thought leaders.
* 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
* 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
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
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