Project Management In API Development & Manufacturing

The development and manufacture of an active pharmaceutical ingredient (API) is a crucial component of the pharmaceutical supply chain. As such, the sponsor’s selection of a contract development and manufacturing organization (CDMO) is an important part of the success of a drug candidate. The sponsor must place their trust in a reliable CDMO with a proven track record of on-time and on-budget performance. For their part, CDMOs can help build this trust, and ensure on-time and on-budget delivery with effective communication facilitated through a talented group of dedicated project managers.

Cedarburg Hauser Pharmaceuticals has established a 95+% on-time delivery record through the use of a centralized project management system. The key to this successful approach is the central coordination of all aspects of a project by an experienced project manager who acts as a single point of contact, pulling the appropriate resources from throughout the organization into a team to best address the individual needs of the sponsor. This team covers the three areas critical to any project’s success: scientific operations, client services and resource management.

• Scientific Operations Team – Applies tailored scientific expertise to each project, focusing development activities on the most critical steps of the process, providing technical updates and assisting in the preparation of regulatory documentation. 
• Client Services Team – Responsible for all communication with the sponsor. The project manager assigned to the project will coordinate regular meetings with the sponsor to discuss project progress and proactively communicate any developments that may impact the project. The assigned project manager becomes a single point of contact and builds a relationship with the sponsor, vital for effective communication and trust. 
• Resource Management Team– Ensures that the appropriate materials, equipment and staff are allocated throughout the entire life cycle of a project from development through manufacture.