Scientist II, Clinical Product Support
About the Job
Scientist II - Clinical Product Support
Requisition # 127529BR
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
How will you make an impact?
As a Scientist II in the Clinical Product Support Team for the Genetic Testing Solutions Group, you will be responsible for performing studies to support the R&D Troubleshooting and Support function for post market surveillance in the clinical group. You will be contributing and developing processes and mechanisms that facilitate continual improvement of our products and ensure a high level of customer satisfaction for all released products. You will perform experiments focused on product improvements and troubleshooting to resolve field problems in a timely manner.
What will you do?
- The Scientist II, Clinical Product Support will support R&D activities in planning and executing experiments will have responsibility in planning and executing scientific experiments to drive continuous improvements to our portfolio of products that have been launched for infectious disease testing.
- Perform clinical sample extraction, qPCR assay and experiment optimization, experiments in molecular biology laboratories (including a BSL2 lab), including operation of liquid handling systems, on a regular basis.
- Optimize product and process using statistical tools (DOE, MSA, etc.).
- Develop testing protocols; prepare project reports, and present study designs and results in PowerPoint to the project team.
- Support On-Market product and manufacturing troubleshooting with strong “customer-first” mindset.
- Follow regulatory compliance in ISO 9001 and 13485.
- Adapt to fast-paced environment and project priority shift effectively and efficiently.
- Requires a Master’s or Bachelor’s degree in Virology, Microbiology, Molecular Biology or Bioengineering.
- 1-2 years of experience in medical diagnostic product development or on market support.
- Experience with ISO 13485 standards and TrackWise QMS software preferred.
- Proven expertise in data analysis and collation of data from diverse sources. Strong experience in qPCR and molecular diagnostics preferred
- Familiarity with the process of obtaining CE-IVD and/or FDA approval of IVD products (preferably molecular diagnostics) a plus
- Ability to think critically and desire to drive constant improvement
- Highly data-driven/detail oriented with an ability to analyze and interpret results
- Ability to adapt to change and take on unexpected challenges
- Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple/changing projects and priorities.
- Excellent communication skills both written and verbal
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