Master Project Schedule SME and Project Manager with over 15 years of experience in setting up and managing web-based Microsoft Project and Primavera integrated project schedules. Highly experienced in all stages of building, managing, and maintaining integrated project schedules and aligning design, construction, commissioning, validation, and operational readiness activities for manufacturing facility renovation and new build projects. John earned his B.A. in Sociology from the University of Guelph in Ontario, Canada.

 

• Develop and manage server-based Microsoft Project and Primavera Schedules on biopharmaceutical projects for Commissioning, Validation, and QC Analytical Method Transfer to a newly constructed facility.

• Lead project update meetings to track progress on scheduled activities and to mitigate delays for items tracking as late.

• Run Production Line Deep Dive meetings to resolve timeline issues caused by construction delays or inter-department confusion for a new biopharmaceutical manufacturing facility.

• Develop SharePoint sites for inter-department and inter-organizational collaboration amongst project teams.

• Manage, maintain, and train on SharePoint Systems.

• Project Manager for Commissioning and Validation of facility utility systems on a new manufacturing facility.

• Execute Commissioning and Validation protocols.

• Project Manager on QP Audit for cell therapy/ T-Cell/ CAR T treatment filing, including scheduling and managing one year of audit response activities.

• Project Manager QP Audit prep including scheduling of audit training/ prep sessions and execution of Mock Audits.

• Project Manager for PAI Readiness for cell therapy/ T-Cell/ CAR T treatment filing.

• Develop schedule for PAI Readiness prep and review FDA PAI Readiness checklists with department leads.

• Project Manager on 3 Phases of PPQ execution for cell therapy/ T-Cell/ CAR T treatment filing.

• Project Manager on facility shutdown for HEPA Certification and EMPQ, Media Simulations.

• Project Manager on GMP Analytical Lab Expansion for cell therapy QC Analytical Testing.

• Set up Key Performance Indicators and resource tracking based off integrated schedules. 

• Develop schedules and reporting to address and reduce the backlog of manufactured cell therapy/ T-Cell/ CAR T lots that require specific QC assays to be executed in order to release.

• Schedule Lot disposition activities required to release cell therapy/ T-Cell/ CAR T lots for clinical and commercial use.

• Prepare and update slide decks for management and executive-level status reporting.