Summary

The Process Expert for Upstream will be responsible for supporting manufacturing with technical knowledge within a defined discipline of Upstream operations including mammalian cell culture, harvest, seed train operation etc).

About the Role

Key responsibilities:

• Attend to production emergencies and act as first line of defend for operation-related troubleshooting and recommending corrections.
• Set up and ensure that routine manufacturing processes are effective and efficient
• Attend to any quality incident and act as deviation investigation owner/ CAPA owner as required.
• Author/ reviewer for manufacturing related documents e.g. BRs, SOPs
• Conduct operations and process monitoring, trending and optimization
• Support cost reduction or yield/productivity improvement projects related to operations as needed
• Support change control by owning or leading MU related actions
• Actively support internal or external audit as Manufacturing representatives
• Provide operations / user input/ Assessment and support equipment/area/system/facility modifications or acquisitions related to MU
• Provide inputs in SAP MM setup.

• Minimum Bachelor degree in Chemical, Mechanical Engineering, Biotechnology or Life Sciences
• Fluent in English
• Minimum 3 years of experience in commercial manufacturing biotechnology processes i.e. cell culture is required.
• Must have an understanding of pharmaceutical industry trends and practices.
• Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and qualification and validation required.
• Must have experience with production scale equipment such as stainless steel tanks, bioreactors, centrifuges, filtration systems, control systems (e.g. DCS or other SCADA, etc.) and CIP/SIP systems.