Description:
The successful candidate will be responsible operations at Alexion’s College Park packaging plant in Dublin. The position requires effective cross-functional collaboration with external and internal partners including internal device/FP subject matter experts, Global technical Operations, device development team, New Product Introduction (NPI) team, Global Supply Chain, Engineering, Operations, Quality, and Regulatory partners.
The Finished Product Packaging Operations Lead will be responsible for leadership through all phases of the clinical/commercial/medical device/finished product (FP) lifecycle, including technology transfer, validation, and routine device/FP manufacturing.
Job Duties & Responsibilities
- Drive and facilitate the strategic recruitment & selection process of a balanced and effective team.
- Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can thrive and continuously improve.
- Manage an effective shift operations team structure ensuring communications and human factors are optimized. Maximize the utilisation of internal manufacturing capabilities to ensure cost-effective, compliant, and on-time supply of products.
- Routinely manage the key drivers of plant productivity – OEE, Utilisation, Right First Time, Standard Work, Quality and Safety investigations, Continuous Improvement initiatives. Ensure the operations team is focussed on lean behaviours and relentless in the pursuit of eliminating waste and improving our sustainability.
- Incorporate a world class Safety and Quality and Right First-Time culture in the Operations team.
- Represent the function for all GMP facility inspections, internal and external working closely with the supporting functions to ensure inspection readiness
- Lead the operating performance and utilisation of resources, planned launches of new products, and need for continuous improvement of product flows to optimize the speed and efficiency of the supply chain while increasing robustness and decreasing costs.
- Take ownership for functional and project budget management & timeline adherence. Accountable for ensuring finished product operation is maintained appropriately
- Develop and maintain strong and effective relationships with partners at College Park including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance. Contribute to best practice sharing with Manufacturing colleagues at other Alexion facilities.
- Incorporate Operational Excellence (OE) tools and integrate OE methodologies as an operating fundamental.
Essential Qualifications
- A minimum of 10 years’ experience in Manufacturing Operations in a biopharmaceutical company
- Demonstrated leadership of technical and operational teams within a biopharmaceutical operations organization
- Excellent people management, communications, and decision-making skills
- Sound judgment and comfortable operating in a challenging, fast-paced, and demanding environment.
- Innovative, with strong focus and proven experience in delivering continuous improvement through the use of the latest process excellence tools.
- Undergraduate degree in science or engineering required.