This organisation are focused specifically on the manufacture of monoclonal antibodies at their new facility covering both drug substance for clinical trials and commercial product. They currently looking for an enthusiastic Process Scientist to join their operations in both upstream and downstream processes.
- Operating process & equipment in a clean room environment, in accordance with batch record, user manuals, current standard operating procedures, safety requirements and GMP. Be capable of understanding and responding appropriately to adverse events.
- Complete tasks required to meet production schedule and batch preparation including equipment set-up and cleaning, receiving and verification of all raw materials, filter integrity testing, running autoclave cycles, sampling, clean-room housekeeping, i.e. gowning/ consumables stock-up.
- Adhere to validation requirements for new equipment & processes to the appropriate standards.
- Assist with the development, review and up-dating of Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture.
- Provide support for other processing activities including media and buffer preparation. Process sampling and sample testing with analytical equipment, pH, conductivity, cell counting, and routine calibration of same.
- Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.
- BSc in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent GMP experience.
- 3-5 years relevant experience in bioprocess development and/or manufacturing, specifically on cell culture / bioreactor systems.
- Background in mammalian cell culture and/or purification process unit operations and awareness of the potential impact of equipment on biological molecules.
To find out more apply online or call Preneta Naidoo directly for a confidential conversation on + 353 6321870.
Salary: On Application