Staff Scientist, Molecular Biology

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Job description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $36 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?**

We are seeking a Molecular Biologist / Laboratory Technician to join our team to follow the development of next-generation sequencing assays to be used in clinical laboratories in the future. You will contribute to our products' clinical validation and further development based on the Ion Torrent sequencing technology, which is rapidly changing the speed and scalability of clinical sequencing for oncology. Responsibilities will include experiment planning, execution, and data analysis. A background in molecular biology, biochemistry, or similar discipline is required. Hands-on experience in molecular biology and diagnostic laboratory is a must. The activities related to this opening will be carried out at Mayo Clinic Facilities in Rochester, as part of a larger collaborative project focusing on Oncology/Hematology with the Mayo Clinic Diagnostic Team.

**What will you do?**

+ Verification and Validation Studies in preparation for a PMA submission to the FDA

+ Diagnostic assays that comply with regulatory standards such as FDA and CE Marking

+ Work in a molecular diagnostic laboratory and perform experiments daily within a team

+ Perform complex analytical validation experiments using Next-Generation sequencing on multiple Ion technology platforms

+ Do data analysis in Excel and other analysis software, prepare presentations in PowerPoint, present results to the team at group meetings

+ Work with team members in a collaborative environment

+ Kit forecasting and kit management for analytical validation studies

+ Troubleshoot assay issues and failures and develop a troubleshooting diagnostic toolbox

+ Orthogonal assay development, feasibility, and validation

+ Will need to maintain complete and thorough documentation required to meet QSR Design Control, as well as other international standards (e.g., ISO compliance, GLP/GMP requirements, etc.)

+ Needs to be self-motivated, capable of multi-tasking and able to ensure focused and timely execution of projects

+ Take care and attention to all detail part of complex molecular biology protocols

+ Work in a fast-paced environment with supportive teammates

+ Actively participate in the team with a positive and proactive attitude

**Education/ Experience:**

+ B.S. or M.S. with at least 6+ years of experience in an academic or industrial diagnostic laboratory

+ Hands-on experience in a molecular biology laboratory: DNA/RNA purification, quantitation and NGS testing (preferentially but not exclusively with Ion Torrent)

+ Ideal candidates will also have experience working in a CAP-accredited environment

+ Excellent attention to detail in record keeping and documentation

+ Experience in IVD testing in a core laboratory facility is a plus

+ Knowledge of Oncology/Hematology testing is a major plus

+ Must be tolerant to change, ready to take on new challenges and open to learning new skills, anticipate needs and problems, while creating solutions

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.