Ensure that the Alexion business needs and priorities are clearly understood and that the project execution plan reflects the scope and schedule of these needs and priorities.
Lead the project team through all project phases from design through to regulatory submission. Engage site functional SME support (Tech Services, Operations, Engineering, and Quality etc.) as required.
Develop project controls (Project Execution Plan (PEP), schedule, risks) to ensure alignment of project timelines with business needs.
Communicate progress against plan on a regular basis and develop mitigations for project risks / delays. Prepare monthly metrics on project performance, achievements, and statistics.
Work closely with other site functions to ensure a smooth transition between project and operational phases.
Responsible for the project management support for the NPI/Technology Transfer of a product across the network using the Alexion TT Business Process from initial SG1 agreement to SG6 Regulatory approval.
Provide support to the Technical team in creating project management reports/ schedules/plans etc.
Organise and facilitate project meetings / Stage Gate meetings in conjunction with the TT leader.
Ensuring appropriate internal/external communication
Ensure the appropriate resources are allocated to the project, Leaders and Steering team.
Work with project controls, Finance and function leads to manage costs and cash flow according to the approved capital budget and report costs monthly to the ATO team.
Support the ATO team to continuously improve TT practice across the network using a lean and standardized approach that can be replicated and continuously improved for subsequent product transfers.
Identify current business process or tools that are critical to a successful and lean TT process and participate as required in driving necessary improvements in conjunction with the business owner.
Experience in developing and using Smart Sheet to allow easy tracking of TT Milestones and Metrics.
Experience / Qualification
Demonstrated leadership of technical and / or operational teams or projects within a biopharmaceutical manufacturing organization.
Experience within new product introduction project work is preferred.
Strong track record of leading in a global and matrix environment and working cross functionally with internal and external stakeholders
Ability to quickly establish strong, effective and enduring partnerships with internal and external stakeholders
Strong organizational, change management, problem solving and leadership skills
Strong presentation and communication skills
Team player with the ability to manage multiple tasks simultaneously
Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing, Aseptic Fill Finish and Finished Packaging.
A working knowledge of regulatory requirements for pharmaceutical industry is required.
Operational excellence knowledge and application using Lean or six-sigma tools would be advantageous.
Education
Minimum undergraduate degree in science/business or engineering.
Our 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.
