Senior Program Manager - Technology Transfer

About the role

AstraZeneca's Alexion site is looking for a Senior Program Manager to own 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. The role covers scope, budget, schedule and delivery and works closely with Technical Operations, Supply Planning, Quality, Finance, EM&O and other departments.

Key responsibilities

• Plan and execute multi-discipline technology transfer projects, from planning through to regulatory submission, defining approach, resources, schedule, budget and ownership
• Prepare project charters with business justification, generate cost estimates, budgets and forecasts, and set up cost tracking and cross-charging with Finance
• Track deliverables, run regular status reports on KPIs, schedule and budget, and maintain the decision log and risk register
• Lead the project team through design to regulatory submission, engaging site functional SMEs such as Tech Services, Operations, Engineering and Quality
• Develop project controls (project execution plan, schedule, risks) and communicate progress regularly, preparing monthly metrics
• Facilitate stage-gate meetings with the TT leader and ensure internal and external communication
• Manage costs and cash flow against the approved capital budget and report costs monthly to the ATO team
• Support the ATO team in improving TT practice across the network with a lean, standardized approach, and identify and drive improvements to business processes and tools

Required profile

• Demonstrated leadership of technical and/or operational teams or projects in a biopharmaceutical manufacturing organisation
• Experience in new product introduction projects preferred
• Strong track record in a global, matrix environment with internal and external stakeholders
• Experience of biopharmaceutical bulk drug substance manufacturing, aseptic fill finish and finished packaging
• Working knowledge of pharmaceutical regulatory requirements
• Minimum undergraduate degree in science, business or engineering

Required skills

• Experience with Smart Sheet for tracking technology transfer milestones and metrics
• Lean or Six Sigma tools are advantageous