New Product Introduction Manager
Core
Manage 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.
Role type
Senior Program Manager, Technology Transfer & New Product Introduction
Builds
New pharmaceutical products, drug substances, medical devices, and finished packaging via technology transfer
Domain
Biopharmaceutical manufacturing / Technology Transfer
Required skills
Project management, budgeting and forecasting, risk management, stakeholder management, regulatory knowledge, cross-functional leadership, process improvement (Lean/Six Sigma), data tracking tools (Smart Sheet)
Preferred skills
NPI project experience, biopharmaceutical manufacturing experience (BDS, Aseptic Fill Finish, Finished Packaging), global matrix environment experience
Technologies
Smart Sheet
Responsibilities
Plan and execute multi-discipline Tech Transfer projects; Prepare project charters including business justification; Generate project cost estimates, budgets, and forecasts; Track project deliverables and provide regular status reporting; Manage decision logs and risk registers; Lead project teams through all phases from design to regulatory submission; Develop project controls (PEP, schedule, risks); Organize and facilitate Stage Gate meetings; Ensure appropriate resource allocation; Support continuous improvement of TT practice using a lean and standardized approach
Seniority
Senior, hands-on IC