New Product Introduction Project Manager

About the Opportunity

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.

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

About You

Experience in developing and using Smart Sheet to allow easy tracking of TT Milestones and Metrics.

Eligibility

• 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

Benefits

- 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 the pharmaceutical industry is required - Operational excellence knowledge and application using Lean or six-sigma tools would be advantageous - Education: Minimum undergraduate degree in science or engineering

About Company

This is where information about the company would go.