
Day Manufacturing Team Lead
- Ireland
- Permanent
- Full-time
- Working assigned day patterns to meet business needs and operations schedule.
- Coordination of operations team to meet production schedule in a safe, compliant and cost-effective manner.
- Completion of pulse walkdowns to ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
- Troubleshooting of process issues and escalating/collaborating with relevant support to resolve in a timely and effective manner.
- Support of Project and Commissioning/ Qualification activities as required
- Deputize for area manager
- Employ strict aseptic technique to all cell culture activities.
- Monitor and control, media harvest hold area.
- Continuous monitoring of cell culture process.
- Media filtration and storage.
- Assembly and disassembly of the Bioreactor vessels.
- Assembly and disassembly of cell culture recovery equipment (ATF/Biomass systems).
- Chromatography processing of biopharmaceutical product using Unicorn/ Delta V control system.
- Filtration, Virus filtration and Ultrafiltration of purified product.
- Final filtration, filling and finishing of purified product.
- Assembly and disassembly of Operations equipment for cleaning and sterilization.
- Operation of washers and autoclaves to clean and sterilize equipment.
- Operation of COP and SOP booths.
- Buffer and media preparation.
- Third level or equivalent qualification
- Demonstration of leadership capabilities in previous roles
- Understanding of the requirements of cGMP and familiarity with other relevant regulatory requirements
- Scientific or Technical Qualification
- Supervisory experience
- Operations experience within a GMP regulated environment
- Operations experience within a Life Sciences or Biopharmaceutical environment.
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