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 .
Job Title: Staff Scientist Product Support
The Staff Scientist is responsible for leading product change and support projects, transferring of in vitro diagnostic devices (immunoassay and clinical chemistry) from external partners, and providing support to Regulatory and Quality to meet regulatory requirements and resolving complex technical problems to meet the site's needs. This includes thoughtful selection of critical materials, innovative design of reagents, assay protocols, product performance characterization studies, manufacturing processes and test methods, specification setting, critical data analysis, succinct presentation and report preparation. This role is critical to the success of the company through revenue generation via product launch, process improvement and/or product support as needed . Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Middletown, VA | Clinical diagnostics Division
What will you do?
This position requires a strong technical background and an understanding of practical and statistical approaches to product development and product support. In addition, the position requires a sound ability to trouble shoot product design problems encountered during product development, scale-up, and support and an understanding of experimental design (DOE) and its application to evaluating, optimizing and troubleshooting product design and formulations.
- Identifying manufacturing processes for new products and improvement opportunities for existing products as needed.
- Facilitating the transfer of new materials to the facility by working with manufacturing and QC laboratory personnel.
- Initiating and carrying out product problem solving and product support activities.
- Evaluating data and preparing technical summaries and supporting reports to document completion of work assignments.
- Leading and supporting specific projects by effectively identifying key activities.
- Designing, conducting and evaluating complex projects, experiments and trials associated with product transfers. Leads complex trouble shooting and process development efforts and assists the coordination of interdepartmental tasks to achieve timely completion.
- Evaluating analytical results and determines conformance to draft/final product specifications.
- Consulting in the qualification of new product manufacturing processes, application of new manufacturing equipment and/or the modification of manufacturing equipment/process, including those associated with contract manufacturing events and product transfers.
- Preparing data summaries and/or reports for technical input.
- Conducting research experiments to identify alternative raw materials and to improve existing products. Uses statistical methodology to design experiments and analyze data.
- Providing mentoring and guidance to Scientists within the department to support professional training and scientific knowledge.
- Supporting Risk Assessments and conducting Risk Analysis on a variety of issues/topics.
How will you get here?
- BS with 6+ years experience, or MS with 5+ years of experience, or Ph.D with 3+ years of experience. Preferred degree in Biochemistry, Chemistry, Biology, or Life Sciences degree
- Strong laboratory and technical hands on skills required
- Strong Analytical Chemistry, Clinical Chemistry, or Immunoassay background required
- Strong ability to design and conduct product development experiments, perform product troubleshooting studies and to evaluate the progress of the respective project(s).
- Strong problem solving skills.
- Understanding and familiarity with 510(k) submissions and associated requirements.
- Strength in planning and coordinating design; and direct experiments of variable complexity.
- Knowledge of GMP and ISO requirements
- Strong knowledge of word processing, spreadsheet programs, powerpoint, and statistical analysis required
- Strong writing & presentation skills required
- Product development or support experience required
Knowledge, Skills, Abilities
- Strong documentation and strong organizational skills required
- Works well in a team setting
- Pays attention to detail
- Be agile with changing environments and execute tasks timely
- Shows initiative by taking on new tasks, beyond what is generally expected
- Inspires and co-ordinates people to achieve specific goals
- Generates ideas to improve current processes
- Sets example by demonstrating excellence
- Demonstrates leadership qualities
- Help coordinate tasks within the team
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