Senior Project Manager
Current
Bothell, Washington, United States
- Led and significantly contributed to the LaunchPad plant operational startup, including: systems implementation, qualification and validation, and facility operational readinessactivities
- Developed, implemented, and maintained a comprehensive integrated timeline to achieve operational readiness, including: Pharmaceutical Quality Systems, Electronic Systems, CQV, Mfg. Operations, QC Laboratories.
- Coordinated and liaised with 12+ workstreams, ensuring execution planning, tracking progress and metrics, identify and escalate issues/challenges, work with the teams to provide monthly dashboard updates to Core Team.
- Assumed full responsibility for all other assigned projects and ensured project(s) are delivered in accordance with site requirements and timelines.
- Developed/implemented plant scheduling tools, capable of both master production plant scheduling and finite operations scheduling for both drug substance and drug product production.
- Actively engaged and participated in Supply Planning meetings to ensure that plant production meets Product Supply needs for both clinical and commercial programs.