Process Development Section Lead
5 days ago
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.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.
What is the role?
The person in this role is responsible for managing a team of manufacturing engineers to support process development at Aerogen. Working in a diverse cross-functional team to deliver technical projects to commercialization. This role represents a great opportunity to support Aerogen’s long term growth and ambition plans. As a Section Lead, you will have strong organizational and people leadership skills with the ability to identify creative and innovative solutions. You will embrace change and work collaboratively with others.
What are the 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 “We Care” Cultures and Values program within the PD team.
14. Perform other assigned tasks as directed by Manager or Head of Department.
What education and experience are required?
A minimum of Level 8 degree in a relevant STEM discipline.
8+ years of relevant experience.
What key skills will make you great at the role?
1. People Leadership: You have experience in managing and developing a cross-functional team with proven ability to mentor and coach others.
2. Technical Experience: Established SME experienced in the introduction and validation of new processes and technology. You look to other industries for best practices and opportunities to leverage new technology for the benefit of Aerogen growth and service.
3. Project Planning: Lead and execute project deliverables by planning, monitoring, adjusting, and communicating project activities to ensure that project deliverables, timelines, risks and budgets are met, including developing contingency plans. You share learnings and knowledge.
4. Collaboration: You are a strong collaborator, you are an effective communicator with strong interpersonal skills; written, verbal and presentation. Identifies and addresses roadblocks in a respectful and accountable way.
5. Creative thinking: You will apply engineering principles to advance ideas from concepts to value-added results. You actively seek ways of applying best practices in your area of expertise in Aerogen.
6. Highly motivated self-starter and able to work in a dynamic environment with little supervision or daily direction.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone Here is an idea of what we offer:
1. Excellent medical care.
2. Bonus & Pension.
3. ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
4. We pledge 1% of profits and time to charities and organisations.
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
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