New Product Introduction Manager

Reports to: Assoc. Director Tech Transfer

Location: College Park, Dublin, Ireland

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.