Project Manager, Cell Therapy Business Systems

Role Summary

The Project Manager, Cell Therapy Business Systems leads digital and enterprise systems projects critical to the manufacturing, logistics, and quality operations of cell therapy products in AstraZeneca's Cell Therapy division. This Associate Director-level role is based in Santa Monica, CA or Gaithersburg, MD, reporting to the Head of Business Planning and Operations and collaborating with the Director of Business Systems to ensure successful project execution.

Responsibilities

• Lead end-to-end implementation and enhancement of enterprise systems (such as cell orchestration platform) supporting cell therapy supply chain and manufacturing.
• Be the bridge between IT, operations, and external vendors to ensure system capabilities meet business needs
• Define project scope, timeline, resources, and milestones for system initiatives
• Manage matrix project teams and drive execution of project priorities
• Coordinate user requirements, testing, validation, documentation, and business deployment activities
• Ensure project understanding of Chain of Identity (COI), Chain of Custody (COC), Plan-To-Make, Order-To-Cash, and regulatory requirements and internal policies processes
• Create detailed project or business plans to manage project scope, deliverables, releases, risks and mitigations
• Support development of long range plans for system innovations / enhancements according to business strategy
• Coordinate development of project readouts to governance and senior leadership
• Track project KPIs and report to senior leadership, including risk mitigation and change management updates.
• Manage the project information repository
• Manage the project budget
• Manage the identification and escalation of potential issues/risks or obstacles
• Lead change management efforts to improve adoption of new products and technology solutions, providing training, support, and communication partners at all levels.
• Communicate and build relationships with a broad spectrum of audiences at all organizational levels.

Qualifications

• Required: Eight (8) years with BS/BA, or six (6) years with MS/MA, in Life Sciences, Biotechnology, Information Technology, Computer Science, Engineering, or a related field.
• Preferred: Experience in cell and gene therapy.
• Required: Experience with all phases of project management, with expertise across a variety of technology project areas in supply chain, manufacturing, quality operations, and clinical systems.
• Required: Knowledge of supply chain and cell therapy workflows.
• Required: Proven track record in the following applications: Cell orchestration, ERP, MES, or LIMS.
• Preferred: Project management certification (PMP) is desired.
• Required: Experience with project management tools (e.g. MS Project, Smartsheet).
• Required: Experience working with matrix teams and managing complex programs in a regulated and enterprise level.