Implementing a project office and phase model for biotechnology capital projects

Bringing biotechnology products to market is a challenging endeavor. Relative to other industries, investment in R&D is quite high in the biotech industry [Technology Review, 2005]. In addition, the biotech industry is critically dependent on manufacturing process innovation [Pisano, 1997; Lim et al., 2006]. The manufacturing processes used to produce these complex medicines must satisfy stringent regulatory and quality requirements. These manufacturing processes are developed through the execution of large capital investment projects. The projects are characterized by long lead times, high levels of complexity and coordination, intensive use of resources, and sizable technical, financial, and regulatory risks. With all these challenges, it is clear that concentrated management attention and excellent project practices are critical to success. This study will describe the efforts of a biotech firm to create a project office center of excellence. We will examine how the project office implemented a comprehensive capital project phase model, as well as providing details on the phase model itself. A range of organizational, technical, and behavioral obstacles will be discussed, along with the approaches used to overcome these obstacles. We will offer lessons learned on how to implement change and improve project performance.