Position Summary  

The role of New Product Introduction (NPI) Manager is responsible for the program management including scope, budget, schedule and delivery for the Technology Transfer and introduction of a new product, drug substance, drug product, Medical Device and Finished Packaging either to an internal Alexion site or an external CMO site. . 

This role will collaborate closely with Technical Operations, Supply Planning, Quality, Finance, EM&O and other relevant departments. This role will work closely with the internal Alexion site or an external CMO to plan and execute a multi-discipline Tech Transfer project, including project approach and resource needs, schedule, budget and ownership throughout the project delivery phases.  

Principal Responsibilities 

• Plan and execute multi-discipline Tech Transfer projects, including project approach and resource needs, ownership through the project delivery phases of Planning, Process  

• Prepare project charters including business justification for new projects. 

• Responsible for the generation of project cost estimates, budgets, forecasting, and long-range plan. In conjunction with Finance ensure that there is an appropriate mechanism established for cost tracking/transfer and cross charging. 

• Track project deliverables, provide regular project reporting on status to plan and KPIs, schedule and budget reports 

• Manage the decision log and risk register for the project  

• 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.  

Date Posted

Closing Date