Biotechnology Manufacturing Program Management
PROJECT OVERVIEW
CAI provided program management consulting services for a global biotechnology manufacturing company executing multiple interrelated projects at one of its facilities. The projects included qualifying two manufacturing trains and preparing regulatory submissions for product commercialization. CAI analyzed the interdependencies and resource requirements across all projects while facing schedule challenges due to technical issues and resource constraints. Our expertise in biotechnology manufacturing operations enabled a robust analysis of the situation. CAI also leveraged CQV services to plan, coordinate, and execute cleaning validation on one manufacturing train. CAI developed and presented recommendations to site and senior leadership, outlining actions necessary to achieve critical goals within aggressive timelines. The recommendations were adopted and implemented, helping the site meet its schedule and financial commitments.
Topics Covered
- Multi-project program management in biotechnology manufacturing
- Resource allocation and scheduling optimization
- Regulatory submission preparation for product commercialization
- Cross-functional coordination (engineering, validation, quality, operations)
- Critical path analysis and schedule compression techniques
- Strategic recommendations for meeting corporate financial commitments
- Change management in complex manufacturing environments