Serves as a primary contract for project management of key Clinical Supply Chain documentation, tasks, and packaging activities in a GMP environment. Owns and supports readiness activities for clinical supply packaging operations. Owns inventory management system set up activities required to drive clinical supply packaging operations.

Responsibilities

• Ensures system set up components are available on time to support Clinical Packaging Production as needed. Owns design, creation, and approval processes for inventory management system activities
• Identify and lead opportunities for process improvements within and cross functions. Responsible for creating and maintaining processes and procedures related to group activities.
• Extract job specific information from planning system to independently create protocol-specific packaging work orders. Serves as primary representative for packaging job readiness in all packaging operations meetings.
• Provide support for pre-approval access and investigator-initiated studies.
• Act as a key interface between project management group, packaging operations, and QA, influencing when needed to ensure packaging activities are set up appropriately and efficiently
• Identifies, develops, communicates and tracks task completion dates, activities, logistics, and milestones in support of CSPMs to ensure the timely availability of investigational drug supplies.
• Serves as trainer to newer team members for all job responsibilities. Develop and maintain up-to-date Training Module for Center of Excellence. Review and update training matrix for all departmental employees as required.
• Translates stability and pre-packaging requests into an executed packaging design. Owns complete process from system set-up, to work order requests, to material transfers, as needed.