摘要
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.
Essential Requirements:-
- 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.
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Innovative Medicines
SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
Technical Operations
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