A Director of External Manufacturing is required by CareerWise Recruitment for our major Biologics client.
Operating from Limerick, you will be accountable for CMO's throughout Europe.
Role of this position
- Oversee all aspects of clinical and commercial parenteral drug product filling, labelling and packaging operations at CMOs within Europe.
- Build, lead and manager a high performing team by hiring and developing skilled talent in all aspects of drug product manufacturing.
- Lead and continually improve manufacturing partnership governance processes, define key meetings and agendas, establish efficient issue escalation and resolution processes, oversee manufacturing partner execution and performance, implement core and custom KPIs that enable proactive action to emerging issues in manufacturing and supply.
- Ensure DP Manufacturing Teams (DPMTs) are sufficiently staffed and trained for rapid response to manufacturing events, proactively identify issues, effectively determine root cause, and implement effective CAPAs.
- Support and collaborate with the Drug Product Project Management and Quality Assurance organizations to ensure successful technical transfers, process validations and CapEx project executions within your manufacturing partnership network of responsibility
- A degree, preferably a Master's, in a scientific discipline
- 12+ years of related experience in a biopharmaceutical cGMP environment.
- 5+ years in a management and/or leadership position
- Demonstrated leader with expert knowledge of parenteral manufacturing, device assembly and finished label and package.
- Excellent at building internal and external partnerships, efficient at identifying and removing barriers for team and projects, and effective at communicating to a wide audience of experience, skills and expertise.
- Demonstrated technical expertise in drug product manufacture and/or product development.
- Working knowledge of clean room or classified area requirements.
- Knowledge of transferring aseptic parenteral filling, device assembly and finish label & pack operations.
Please call Brian Flynn today for further information on 021 4297423 or email: firstname.lastname@example.orgCareerWise Recruitment (In Search of Excellence)