About Aerogen:
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery.
Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients' lives every day, having already reached 20 million patients in over 80 countries.
We believe in innovation and finding solutions to complex problems. We lead the way in delivering better patient care.
Job Role:
The person in this role is responsible for managing a team of manufacturing engineers to support process development at Aerogen.
This role represents a great opportunity to support Aerogen's long term growth and ambition plans.
Key Responsibilities:
1. Plans, organizes and delivers direction to engineers and project teams across a diverse range of projects.
2. SUPPORT TEAM MEMBERS IN THE DEVELOPMENT OF THEIR TECHNICAL ABILITY, PRODUCT KNOWLEDGE, AND COMMUNICATION SKILLS.
3. Develop team members through establishing and communicating their goals and expectations, empowering them to make decisions, providing them with timely feedback and setting them up for success.
4. Maximise team member and overall team performance.
5. Responsible for the identification and development of talent, including performance management, coaching, succession planning and mentoring for high performance.
6. Project manage cross-functional teams delivering on the Process Development projects.
7. Lead the validation strategy and execution for process change, through to commercialization of new products/processes and capacity expansion.
8. Support all customer, FDA and NSAI audits when required.
9. Use of best practice Project Management Tools, Methodologies & Processes for Projects.
10. Establish and Sustain Operational Readiness Project requirements for successful integration of Process Development Projects into Manufacturing and commercialization. Implement continuous improvements to support best practices for process transfers.
11. Ensure R&D, Regulatory, Operations and Commercial requirements are delivered including presentation and approval of stage gate project reviews.
12. Support and review of process and equipment documentation including DV, URS, FAT, SAT, IQ, OQ, PQ, PPQ protocol development, implementation, and report completion to timelines.
13. Act as a role model for Aerogen