Reporting through the site manufacturing and technology head.
•Supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations.
•Supporting process improvement and troubleshooting with 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 LeanSixSigma tools in the Process Sciences group by:
Securing continuity of an appropriate LSS/CEM level of knowledge.
Facilitating problem solving & risk assessment (FMEA) projects/meeting.
Making problems visible and strive for continuous improvement.
•A master’s degree (or higher) in Biological Sciences/Chemistry /ChemicalEngineering/Biological Engineering.
•0-3 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 modelling.
•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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