This is an 11-month contract.
Supporting and executing experimental design, data analysis, and interpretation to resolve complex cell culture deviations.
Supporting process improvement and troubleshooting with an end-to-end product focus.
Provide technical support investigations, new process introduction, or change implementation in commercial manufacturing operations.
Authoring and reviewing development operating procedures and technical reports.
Supporting global regulatory submissions as needed.
Applying Lean Six Sigma tools in the Process Sciences group by Securing continuity of an appropriate LSS/CEM level of knowledge., Facilitating problem-solving & risk assessment (FMEA) projects/meetings.
Making problems visible and striving for continuous improvement.
A master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
1-3 years experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing).
Experience in drug substance process development, process characterization studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics, and process modeling.
Experience in executing experimental programs in the laboratory.
Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design-Expert software)
Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
Knowledge of and experience in applying Six Sigma and Lean methodologies
Desirable evidence of Continuous Professional Development
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