Job Description

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.

Job responsibilities include:

* This is a hands-on lab position, including mentorship and project lead responsibilities
* Sits on Development team to serve as main liaison between R&D and Transfer/Ops
* Responsible for ensuring that products are adequately developed to enable smooth Design Transfer
* 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 to support specification setting / appropriate acceptance criteria
* Ensures DHFs and technical files meet applicable standards. Documentation under design control to ensure quality product development.
* Supports technical aspects of regulatory submissions
* Drives continuous process improvement

How will you get there? Experience required:

* PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering with at least 5 years of experience working in regulated markets
* Experience in late stage devt, design transfer to manufacturing, and V&V
* Developed and launched commercial qPCR Assays
* Demonstrated teamwork under tight timelines
* Strong experience working under ISO 13485, 21 CFR Pt 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
* Strong communication and presentation skills are essential
* Highly collaborative; enjoys working in a diverse team, contributes to a positive work environment
* Self-motivated, independent, proactive, organized, diligent, and very nimble *EVRD2020 *GTSDouble