Provides moderately complex analyses in a biology environment within defined procedures and practices. Participates in development of scalable processes with improved product yield and reduced costs in a biologics environment. Supports internal development and/or manufacturing operations. May research and implement new methods and technologies to enhance operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions. Maintains lab equipment.
1. Assists with the design of experimental plans based on the defined deliverables.
2. 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.
3. May function as a process subject matter expert in a cGMP environment.
4. Records results in notebook accurately, clearly, and regularly.
5. Assists with preparing protocols, reports, and test methods.
6. Maintains and ensures safe laboratory environment and work practices.
7. Helps to maintain laboratory and order common supplies.
8. Executes, records, and evaluates experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.
9. Develops recombinant protein purification processes, including chromatography process, ultrafiltration / diafiltration, nanofiltration, process characterization and optimization, process scale up, scale down model qualification, viral clearance validation. Assists with development of transfer of purification processes which can be scaled up for protein production and facilitates the Technology Transfer to Downstream Manufacturing group.
Bachelor's degree or Master'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. AKTA experience preferred. Experience using advanced statistical software packages and experience with design of experiments (DoE) software (i.e. MiniTab, JMP) preferred.
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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.
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