Title: Scientist II, Analytical and Formulation Sciences
Location: St Louis, MO
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.

How Will You Make An Impact?

Provides complex analyses in an analytical process impurity and potency group 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. Researches and implements new methods and technologies to enhance operations. Makes detailed observations and reviews, documents, and communicates test results.

What Will You Do?

• Knowledge and experience with a variety of biological assay techniques such as ELISA (enzyme-linked immunosorbent assay), colorimetric and/or kinetic enzyme activity assays, protein content assays (i.e. Bradford, BCA, Lowry, etc.), biotinylation or other protein conjugation techniques. Must have experience using manual and electronic pipets (single and multi-channel) and microtiter plate readers. Plate washer experience is desirable.
• Previous experience quantifying DNA by qPCR. Experience using Kingfisher Flex or MagMax Express purification systems are desired.
• Conducts moderately complex analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.
• Designs experimental plans based on the defined deliverables. Executes appropriately record and evaluates experimental data, including the writing and revising of process development reports and technology transfer protocols as needed.
• Prepares protocols, reports, and test methods and writes SOPs. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records results in notebook accurately, clearly, and regularly.
• Recognizes and reports unexpected results and non-routine analytical and product problems; recommends solutions.
• Maintains and ensures safe laboratory environment and work practices.
• Maintains and troubleshoots analytical instrumentation as needed. Helps to maintain laboratory and order common supplies.
• Performs all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
• Ability to function in a rapidly changing environment and balance multiple priorities moving from one project to another as priorities change.

How Will You Get There?

Education:

Bachelor or Master's degree in biochemistry, biology, chemical engineering, molecular biology, chemistry, or a related field.

Experience:

With Bachelor’s degree, minimum of 2 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory. Relevant industry and discipline experience preferred. Experience using design of experiments (DoE) software (i.e. MiniTab, JMP) preferred. With Master’s degree, no experience required. Relevant industry experience and discipline preferred. Experience using advanced statistical software packages and experience using design of experiments (DoE) software (i.e. MiniTab, JMP) preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.