Staff Scientist - Clinical On-Market Support
Requisition ID: 127531BR
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.
South San Francisco, CA
Genetic Testing Solutions
How will you make an impact?
You will be responsible for supporting the R&D Troubleshooting and Support function for post market surveillance in the clinical group. You will be leading scientists in 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 and work with the quality team to ensure good practices are followed for post market surveillance of our products.
What will you do?
- You will have leadership responsibility in planning and executing for scientific activities to drive continuous improvements to our portfolio of products that have been launched for infectious disease testing.
- Collaborate with a team of R&D experts to help with customer related troubleshooting for clinical molecular diagnostic products.
- Support end to end workflow with a focus on sample prep and qPCR multiplex assay development
- Work with company-wide stakeholders, in quality and field support to develop and improve processes for gathering customer feedback, CAPA, complaint handling, and defect tracking and closure. Where relevant, improve current processes or as needed develop new processes. Identify gaps and plan efforts to close these gaps.
- Demonstrate flexibility, agility and timeliness in managing time and juggling research and development activities.
How will you get here?
Requires a Systems Engineering background or a Ph.D. degree in Biochemistry, Virology, Microbiology, Molecular Biology, or related field. Exceptional individuals with master’s degree and extensive experience will also be considered.
- 5+ years of experience in medical diagnostic product development or on market support
- Experience with ISO 13485 standards and TrackWise QMS software preferred.
- Strong experience in qPCR and molecular diagnostics preferred
Knowledge, Skills, Abilities
- Proven expertise in data analysis and collation of data from diverse sources.
- Have a deep understanding of product design, development and commercialization for life science and/or genetic analysis platforms, content and associated chemistry
- Strong collaborator with ability to motivate and drive product design excellence across internal cross-functional teams in a fast paced environment.
- Must have a good knowledge of the Product Development Process and the inner workings of a large company.
- Good technical writing skills, excellent time management skills and ability to work independently required. Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities.
- Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner
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.