Are you ready to lead the charge in introducing ground breaking medical devices and combination products? As the New Product Introduction (NPI) Project Manager for Device and Packaging, you'll be at the forefront of innovation, overseeing the project management, budget monitoring, and scheduling for new product introductions at the Alexion Dublin Manufacturing Facility. This role goes beyond technical design control and technology transfer, encompassing broader project management responsibilities that coordinate multidisciplinary teams. Your leadership will ensure successful technology transfers, meeting clinical supply readiness and regulatory commitments for new devices and products.
Accountabilities:
- Drive end-to-end project management and coordination for new device and combination product introductions, from feasibility assessments to regulatory approval.
- Develop and maintain standardized work breakdown structures and project schedules to align with design control and operational readiness requirements.
- Support Dublin Operations on CMC device sub-teams and Supply Chain NPI/launch teams, providing updates on progress, risks, and mitigation plans.
- Provide direction to the internal NPI project team, coordinating functional leads across disciplines to execute site activities.
- Plan and execute multi-discipline Tech Transfer projects, ensuring alignment with business needs.
- Develop project controls to align timelines and budgets with business objectives.
- Communicate progress regularly through dashboards with metrics on program performance.
- Ensure compliance with Alexion policies during construction and start-up activities.
- Facilitate project meetings and ensure resource allocation aligns with project needs.
- Lead User Requirements Specification workshops and review technical documentation.
Essential Skills/Experience:
- Degree or Masters in science or engineering discipline or vocational qualification specific to medical device/combination product engineering or manufacturing
- Technical knowledge and experience in Medical Device design control/design transfer or device/combination product manufacturing
- Experience in Technology Transfer and new product introduction projects
- Working knowledge of regulatory requirements for the pharmaceutical industry
- Strong organizational, change management, problem-solving, and leadership skills
- Excellent presentation and communication skills
- Ability to manage multiple tasks simultaneously as a team player.
Desirable Skills/Experience:
- 5 years’ experience in pharmaceutical manufacturing, including FP - medical device combination product manufacture
- Knowledge of operational excellence using Lean or Six Sigma tools.
At AstraZeneca, we are driven by a passion for innovation and a commitment to making a difference in the lives of patients with rare diseases. Our entrepreneurial spirit is matched by the strength and resources of a global biopharma leader. Here, you'll find a culture that celebrates diversity, fosters new ideas, and empowers you to grow both personally and professionally. Join us in our mission to change lives for the better every day.
Ready to make an impact? Apply now and be part of a team that's redefining what's possible in healthcare!
Date Posted
16-Dec-2025Closing Date
04-Jan-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.