Job Abstract

Job Description

The Scientist II is responsible for executing procedures, protocols, and processes in support of department projects. This includes but limited to thoughtful execution of assay protocols, product performance, characterization studies, stability studies, manufacturing processes and test methods, specification setting, critical data analysis, succinct presentation, and report preparation with direction from the Team Manager and/or Senior members of the team. This role is critical to the success of the company in protecting the revenue through supporting right first time, timely execution of non-conformances, investigations, CAPAs, process improvement and/or formulation support as needed. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Middletown, VA | The Clinical diagnostics Division produces in-vitro diagnostics for large diagnostic companies, including immunoassay; clinical chemistry; hematology; coagulation and specialty diagnostic products.

• Learn about our Middletown site here!

• This position requires a strong technical background and an understanding of practical and statistical approaches to resolve scientific questions. In addition, the position requires a sound ability to trouble shoot product design problems encountered during formulation and manufacturing.
• Applying knowledge of aqueous chemistry of biochemical, organic compounds, surfactants, polymers and metal salts used in clinical chemistry, immunoassay, coagulation, hematology and specialty diagnostic products to resolve manufacturing problems and drive process improvement.
• Make detailed observations and conduct statistical analysis of data in support of product and process quality. Maintain accurate notebooks/files in accordance with Middletown quality standards.
• Create and review production master records (PMRs) for formulating and manufacturing clinical diagnostic reagents.
• Contribute ideas and suggestions to improve clinical diagnostic reagents’ manufacturing processes and techniques to improve protocols, processes and equipment.
• Engage in high performance work teams to sustain a culture of operational excellence, continuous improvement, and productivity.
• Comply with all company safety, quality, and training procedures and regulations.
• Report all non-compliance and support, engage in, and potentially lead teams assigned to making improvements. 
• Facilitating the transfer of new products and processes 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.
  • Supporting specific projects by effectively identifying key activities.
  • Conducting and evaluating complex projects, experiments and trials associated with product transfers, process improvements, process characterization and stability studies.
  • 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.
• Supporting Risk Assessments and conducting Risk Analysis on a variety of issues/topics.
• May be required to perform other related duties as required and/or assigned.

• Ph.D. degree in Biochemistry, Chemistry, Biology, or Biotechnology/Biomedical engineering or other related discipline.
• Bachelor’s degree (Biology, Chemistry, Biochemistry, Biotechnology/Biomedical engineering or other related discipline with equivalent knowledge and experience) with a minimum of 3 years of experience in a manufacturing/lab environment or a master’s degree with a minimum of 2 years in relevant laboratory/practical work.

Must Have

• Strong Biochemistry, Organic Chemistry, Clinical Chemistry, other chemistry disciplines or Immunoassay background.
• Strong ability to conduct experiments, perform troubleshooting studies and to evaluate the progress of the respective project(s).
• Knowledge of aqueous chemistry of biochemical, organic compounds, surfactants, polymers, and metal salts used in in manufacturing of clinical diagnostic reagents is highly desired.
• Must be a self-starter, have excellent time management and organization skills, a high degree of work quality, attention to detail, and strong communication skills.
• Strong problem-solving skills.
• Must be able to maintain neat, accurate and complete records and logs.
• Advanced experience with Microsoft Office Suite (Excel, Word, and PowerPoint) and statistical analysis software.
• Strong technical writing & presentation skills.
• Ability to learn new skills, databases and programs associated with day-to-day job responsibilities.

• Works well in a team setting.
• Pays attention to detail.
• Is agile with changing environments and timely execution of tasks.
• Shows initiative by seeking new tasks, beyond what is generally encouraged.
• Inspires and coordinates people to achieve specific goals.
• Generates ideas to improve current processes.
• Sets example by demonstrating excellence.
• Demonstrates leadership skills.
• Helps coordinate tasks within the team.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

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