Scientist – Cell Culture- R2

· 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:

o Securing continuity of an appropriate LSS/CEM level of knowledge.

o Facilitating problem solving & risk assessment (FMEA) projects/meeting.

o Making problems visible and strive for continuous improvement.

· 0-3 years’ experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing).

· Experience in drug substance process development, process characterisation 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.

· A master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.