Some opportunities happen only once in a lifetime – like a job where you have the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
The Manager, Device New Product Introduction (NPI) is responsible for the project management and delivery of the scope, budget (where applicable), schedule and quality for the introduction of new medical devices and combination products to be manufactured within the Alexion Dublin Manufacturing Facility (ADMF). The role is not confined to the technical aspects of design control and technology transfer but has broader project management responsibility for coordination of all disciplines represented in the NPI team that are essential to enabling successful Technology Transfer from a receiving site perspective. This requires project management of multidisciplinary project teams including Packaging Operations, Tech. Services, Engineering/Capital Projects, Validation, Automation, QC, and QA to meet the business, technical, quality, cost and supply-readiness objectives, as defined for each NPI project. This includes meeting clinical supply readiness commitments and/or regulatory submission and approval commitments to enable both clinical and commercial supply for each new device or combination product to be assembled, labeled, packed, tested, released and shipped from the College Park Facility.
You will be responsible for:
- Responsible for the end-to-end project management of site activities to enable introduction of new device and combination products; from feasibility scenario assessment and initial planning through to manufacture, regulatory filing and approval.
- Interfacing with PDCS/CMC and Global Supply Chain NPI team stakeholders to provide a single point of contact for the coordination of site activities to support NPI.
- As PM, create and maintain a standardized work breakdown structure and project schedules as necessary to align with and facilitate the delivery of design control and design transfer and operational readiness requirements from a receiving unit perspective, according to the relevant medical device regulations, policies, and procedures.
- Represent Dublin Operations on CMC device sub-teams and Supply Chain NPI/launch teams as required, providing regular updates on progress, risks and mitigation plans as appropriate.
- Provide direction and coordination to the internal NPI project team comprising the functional leads for each discipline as required to execute the NPI site activities. Including as required and not limited to: Alexion Technical Operations, Device Tech Transfer Lead, Packaging Operations, Planning, Validation, Automation, Engineering (system owner), Capital Projects, Shipping, QC, QA, Medical Device Quality, Regulatory Affairs.
- Ensure that the Alexion business needs and priorities are clearly understood and that the program execution plan reflects the scope and schedule of these needs and priorities.
- Plan and execute multi-discipline Tech Transfer projects, including project approach and resource needs, options analysis, through the project delivery phases
- Develop project controls (plan, integrated schedule, risks and cost) to ensure alignment of project timelines and budgets with business needs.
- Communicate progress against plan on a regular basis. Prepare weekly and monthly dashboards with metrics on program performance, achievements, cost reporting and statistics.
- Ensure appropriate internal and external communication is established and maintained throughout the program execution
- Ensure all applicable Alexion policies, guidelines, and procedures are followed in the compliant execution of construction and start-up activities.
- Provide support to Technical team creating project management reports/ schedules/plans etc.
- Organise and facilitate project meetings / Stage-Gate meetings in conjunction with the ATO TT leader and CMC sub-teams.
- Ensure the appropriate resources are allocated to the project
- Support the development of a lean and standardized approach and format for new product introduction that can be replicated and continuously improved for future product transfers.
You will need to have:
- Degree, Masters in a science or engineering discipline or vocational qualification and/or training specific to medical device /combination product engineering or manufacturing
- Technical knowledge and experience of Medical Device design control/design transfer, or device/combination product manufacturing.
- Strong track record of leading in a global and matrix environment and working cross functionally with internal and external stakeholders.
- Demonstrated leadership of technical and / or operational teams or projects within a pharmaceutical manufacturing organization.
- Experienced in Technology Transfer and new product introduction project work.
- A working knowledge of regulatory requirements for pharmaceutical industry is required.
- Ability to quickly establish strong, effective and enduring partnerships with internal and external stakeholders
- Strong organizational, change management, problem solving and leadership skills
- Exceptional presentation and communication skills
- Team player with the ability to manage multiple tasks simultaneously
We would prefer for you to have:
- 5 years’ experience in pharmaceutical manufacturing, including FP – medial device combination product manufacture
- Operational excellence knowledge and application using Lean or six-sigma tools would be advantageous.
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.