- As part of Operational Readiness lead the Manufacturing Manager will lead the Technology Transfer for new biologics products
- Scope includes regenerative medicine manufacturing
- The Manufacturing Manager will delegate tasks and communicate priorities to team members
- Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
- Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
- Lead the process validation.
- Provide direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and in compliance with Quality standards.
- The Manufacturing Manager will lead and manage production operations (aseptic manufacturing, filling and packaging) and production related warehousing & logistics within the bioprocessing plant.
- Manufacturing subject matter expert representing the manufacturing department in internal, global and regulatory audits and maintain an audit ready mind-set in manufacturing areas.
- Maintain and develop quality standards to cGMP guidelines; operations lead in regulatory and customer audits (e.g. HPRA audits, Sterility Assurance, Environmental Health & Safety)
- Take ownership of environmental performance in the manufacturing area and work continuously to ensure the strongest environmental performance possible by proactively and constantly improving control strategies and employee engagement in this area.
- Lead and support investigations in manufacturing and technical deviations.
The next Manufacturing Manager should have a Science, Engineering or BioChemistry degree with at least 5 years’ experience in pharmaceutical manufacturing including technology transfer preferably in the field of aseptic manufacturing operations with at least 3 years of experience at leadership level.
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