Senior Project Manager
CurrentLed 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, Automation Systems, Materials Management, Facilities & Engineering, EH&S, Information Systems, and Human Resources• 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, and ensured deliverables are met according to schedule.• 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.• Developed business processes and guidelines for Plant Mfg. Operations that are aligned with keystakeholders.• Assisted in the generation, tracking, and adherence to Capex and Opex budgets.