Title: Analytical Development Scientist II
Work Location: St Louis
Division: Pharma Services Group (PSG)

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

What Will You Do?

Provides complex analyses within an analytical development laboratory using defined procedures and practices. Performs complex analytical methods and studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities of biopharmaceuticals at all stages of clinical development. Develops, qualifies, and transfers analytical methods. Works with Quality Control and other Operations groups to trouble-shoot and improve existing analytical methods. Makes detailed observations and reviews, documents, and communicates test results.

Key Responsibilities:

• Knowledge and experience with a variety of chromatography techniques: reverse phase, size exclusion, affinity and ion exchange chromatography. Experience utilizing chromatography data systems, Empower 3 preferred.
• Assists with the design of experimental plans based on the defined deliverables.
• Conducts semi-routine and moderately complex tasks and sample analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.
• May function as a process subject matter expert in a cGMP environment.
• Records results in notebook accurately, clearly, and regularly.
• Assists with preparing protocols, reports, and test methods.
• Maintains and ensures safe laboratory environment and work practices.
• Helps to maintain laboratory and order common supplies.
• Executes, records, and evaluates experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.

• Perform various chromatography assays including reverse phase, size exclusion, affinity and ion exchange chromatography. Participate in analytical studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities of biopharmaceuticals at all stages of clinical development.
• Develops, qualifies, and transfers less complex analytical methods.

How Will You Get There?

• Bachelor's degree in biology, chemistry, biochemistry, chemical engineering, or a related field.
• With Bachelor’s degree, minimum of 2 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory.
• Relevant industry experience preferred.
• With Master's degree, no experience required; related industry experience preferred.
• Experience using advanced statistical software packages and experience with design of experiments (DoE) software (i.e. MiniTab, JMP) preferred.