Project Management: The Key to Success for API Manufactures

As PCI Synthesis has grown over the years, we have focused on developing the necessary Project Management skills to manage the complexities of our projects and our resources.

Posted: April 1, 2008

API Manufacturing and Pharmaceutical Manufacturing

As PCI Synthesis has grown over the years, we have focused on developing the necessary Project Management skills to manage the complexities of our projects and our resources. PCI has a dedicated project management team that has been trained to understand how their roles fit into the plans we develop with our customers. Roles and expectations are clearly defined and communication methods have been developed to ensure project success.

It’s not enough to assign one person in the organization as the Project Manager only to have that person chase everyone in the organization for the details to keep the project on track. If the staff isn’t well versed in what is expected of them, the likelihood that a deadline will be met is low. It’s critical that all members of the organization understand the Project Management system that’s in place, how the system works and the importance of carefully executing the plans that are developed for a project. The team may change from project to project, but the project management process remains consistent.

On a typical project, we review the schedules and workloads in all the required disciplines and then assign the project based on the requirements necessary and the availability of resources. Meetings are scheduled with the assigned persons and we go through an exercise of outlining and defining the steps and phases of the project. Gantt Charts are developed and milestones are defined. Communication plans are put in place so that everyone in the room knows exactly what the expected result of the project is and how they fit into the overall process. They all leave the room knowing exactly what steps they will follow and how they will communicate their progress back to the Project Manager and to the team.

Once we have internally determined how best to approach a project, we immediately communicate the plans to our customer. It is critical to make sure that the customer feel they we completely understand their expectations and they feel secure that if there are any deviations whatsoever from the plan, we will inform them immediately. Communication and trust are essential to successfully managing the project both internally and with the customer.

Once a project is underway, periodic teleconferences may be scheduled with the customer and essential members of the team. If a teleconference isn’t necessary, we will communicate via email so that the customer is always aware of where we stand on the project.

Aside from keeping a finger on the pulse in terms of timelines and communication on each project, we also carefully watch the financial aspect of the project. Chemistry doesn’t always perform as planned and changes in chemistry will impact the budget. Additional time may be required to complete a step. Additional glassware may be needed or possibly a filtering step may have been omitted from the technical package when it was initially submitted to us when we submitted our proposal. We ensure that the customer is aware how changes to the plans impact their budget so there are no surprises.

There are always lessons to be learned and improvements we can make so we take a time at the end of each project to make sure we capture that information. PCI has a very high repeat customer rate and we attribute that to how well we manage our projects and live by our commitments. Successful project management is only possible with a strong committed team; a team that is working together to achieve the same goal.

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.