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Thermo Fisher Scientific Scientist II, Process Development in Saint Louis, Missouri

Scientist II, Process Development - Analytical

Requisition ID: 148133BR

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.

St.Louis, MO | Drug Substance Biologics BPS

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 here?

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.

Knowledge, Skills, Abilities

  • Working knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment.

  • Excellent problem solving and critical thinking skills.

  • Solid writing, communication, and presentation skills. Strong MS Excel, PowerPoint, and Word skills.

  • Excellent organization and planning skills.

  • Strong attention to detail and ability to adhere to standards procedures.

  • Ability to design and execute tasks and studies based on the deliverables.

  • Ability to analyze and summarize complex scientific data.

  • Ability to create reports.

  • Ability to function in a rapidly changing environment.

  • Strong attention to detail and ability to adhere to standards procedures.

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

  • Ability to speak effectively before groups of customers and employees.

  • Ability to make decisions that require choosing between limited alternatives to resolve complex problems.

  • Ability to apply complex mathematical concepts to physical problems in areas. Ability to lead and mentor less experienced staff.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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