Key Responsibilities:
In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing. Responsibilities include supporting and creating project schedules, dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.
Your role will focus on building effective Tech Transfer plans and schedules for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.
Supporting Tech Transfer project scheduling activities for FDP.
Supporting New Product Introduction to manufacturing site.
Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
Developing, tracking, and providing project dashboard updates.
Providing good communication plans to cross-functional teams and Process Engineer management.
Ability to apply project management and engineering science to production.
Strong teamwork and excellent interpersonal and communication skills.
Preferred Experience:
Experience in the Combination Product field, focusing on project management and/or manufacturing.
Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and regulatory requirements on a global scale.
Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).
PMP certification is desired.
Additional Skills:
Proactive risk assessment, management, and mitigation.
Ability to lead and succeed in an ambiguous environment.
Strong project management skills.
