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

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 protein conjugation techniques. Must have experience using manual 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 is 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, records 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.

Education:

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

Experience:

With Bachelor's degree, minimum of 5 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory.
With Master's degree, 3 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory.
With PhD, experience with practical scientific application necessary, though related experience not necessary.

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. Relevant industry and discipline experience preferred.

Knowledge, Skills, Abilities

• Deep knowledge of varied aspects or a specialized aspect of discipline.
• Working knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment.
• Solid lab skills.
• 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 standard 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 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 perform all required process steps.
• Ability to apply complex mathematical concepts to physical problems in areas.
• Ability to lead and mentor less experienced staff.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and lab locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Stand up to 25% daily. Walk within lab and between buildings daily. Repetitive hand motions.

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.