Thermo Fisher Scientific Staff Scientist - IVD Product Development in Topeka, Kansas
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?
The Genetic Testing Solutions group is a team of passionate individuals who are deeply committed to making the world healthier through development of molecular diagnostics. This role will be responsible for leading projects to develop and commercialize molecular assay products for both research and clinical applications on Thermo Fisher Scientific sample-to-answer platforms.
This is an opportunity for a highly motivated IVD scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine. The ideal candidate will be a strong team player who is passionate about delivering high quality simple, effective, customer-focused products. The successful candidate will incorporate IVD and molecular biology experience to develop robust, innovative diagnostics.
What will you do?
This is a hands-on lab position, including mentorship and project lead responsibilities
Collaborates with cross functional core teams
Plans and executes IVD development experiments, from proof of concept to validation, regulatory submission and launch
Actively participates as a member of cross-functional product development teams
Leads data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods
Ensures products are adequately developed to enable smooth Design Transfer
Documentation under design control to ensure quality product development
How will you get there?
PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering with at least 5 years of biotech experience
Developed and launched commercial qPCR Assays
Demonstrated teamwork under tight timelines
Strong experience in IVD product development, following ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971
Have submitted 510k/PMA and / or List A CE-IVDD (or List D IVDR)
Design Control & Change control, and experience writing design quality records
Expertise in Process Capability / Six Sigma
Experience participating in audits
Demonstrates passion for problem solving and outside-the-box thinking
Demonstrates passion for mentoring and team development
Strong communication and presentation skills are essential
Must be highly collaborative and always willing to help others
Self-motivated, independent, proactive, organized, diligent, and very nimble
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
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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