30824-NPI Manager-Dublin Contractor

New Product Introduction Manager

Purpose

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 internal or an external CMO site.

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
• 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.
• Prepare monthly metrics on project performance, achievements, and statistics.
• Responsible for the project management support for the NPI/Technology Transfer of a product across the network
• Provide support to the Technical team in creating project management reports/ schedules/plans etc.
• Ensuring appropriate internal/external communication
• 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.

Qualifications

• Minimum undergraduate degree in science/business or engineering.
• Experience in developing and using Smart Sheet to allow easy tracking of TT Milestones and Metrics.
• Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing, Aseptic Fill Finish and Finished Packaging.
• Demonstrated leadership of technical and / or operational teams or projects within a biopharmaceutical manufacturing organisation.
• 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
• 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.