Biotechnology Manufacturing Program Management

A global biotechnology manufacturing company was executing several interrelated projects of strategic importance to its supply chain at one of its production facilities. These projects involved the qualification of two manufacturing trains as well as the associated regulatory submission preparations required for the commercialization of the products manufactured on both trains. Project activities targeted corporate financial commitments and product development/commercialization commitments with partner companies. Due to the aggressive and tight timelines for each project, site resources were being shared across multiple project activities. As a result of technical issues and resource constraints, the client faced challenges associated with the schedule.

CAI analyzed the interrelated activities and identified the interdependencies and resource requirements, which involved examining projects on both manufacturing trains, activities required in preparation for regulatory inspection submission, projects needed to accelerate production rates, and projects focused on small capital site improvements. Following the analysis, CAI provided recommendations to assist the site in achieving critical project objectives while adhering to schedule and financial commitments.