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

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.

What Will You Do?

Provides complex analyses in 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.

Essential Functions:

• Knowledge and experience with analytical chromatography (HPLC and/or UPLC) and assays including reversed phase, size exclusion, affinity and/or ion exchange. Previous mass spectrometry (LC-MS and/or LC-MS/MS) experience is preferred.
• Knowledge and experience with protein characterization including peptide mapping and glycan analysis.
• Hands on experience using Chromeleon, Xcalibur, and/or Empower 3.
• 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.