Project Management: A Technical Point of View

Ronald Malone of SP Pharmaceuticals shares his thoughts on managing the all-important link between the customer and a contract manufacturer.

By Ronald A. Malone, N/A

Project management is the most important link between a contract manufacturer-developer and the customer. If it's good, the customer is happy. If it's not, the customer
is unhappy. It is that simple.

Project management's goal is to complete projects on time and within budget while ensuring the highest quality in process and product. This goal takes on special meaning in the pharmaceuticals industry because it is highly technical and tightly regulated, making professional project management even more critical.

Technical Competence
To deliver on the goal, the pharmaceutical project management team has to be technically competent. This is key to almost everything else. I like to call it technical project management, because it reminds us that we are involved in a technical process
delivering a high quality drug product that meets it's established criteria.

A contract manufacturer can provide strong technical project management by assembling the proper team, employing people from functional areas of the company whom have expertise in various pharmaceutical technologies.

The visible benefits are almost immediately apparent. A strong technical group can speak to the pharmaceutical customer without constantly consulting with functional areas. They can answer questions. This means faster response, sometimes even immediate response. With a clear understanding of technical issues, the project management team knows where the customer is going and how to get them there. They can take a project from beginning to the end.

In short, viewing project management as a technical enterprise produces better solutions.

Capturing Information and Driving the Project
The project managers should be involved from the initial request for quotation, to begin gathering the detailed technical information necessary for the project. They will develop a scope of work, and follow up with the prospective customer to answer any questions or concerns. This is true whether the project is pre-formulation and development, clinical or commercial manufacture.

When the client accepts the quotation, the project manager completes the next level in the documentation process, in which all technical information available is captured and the project is defined from beginning to end and deliverables and milestones are determined for both the customer and the contractor.

The project manager then distributes the scope of work to functional areas for acceptance of deliverables; work is scheduled. This is an important step because it helps define clear roles for project managers and functional department involvement.

Because a technical project management team has a clear understanding of where the project should go, they can take the initiative from the beginning. This protects both the contractor and the customer from the disappointment of over-commitment and failure to deliver on an over-commitment. It also creates the opportunity for the contractor to be pro-active rather than re-active, which makes the contractor a true partner in the process.

Benefits
There are many other benefits to this process. Among them are:

• Providing critical information for timely, accurate quotes.
  
• Assuring a structure for meeting milestones.
  
• Creating a central path for information.
  
• Streamlining and controlling the overall process.
  
• Differentiating between development and commercial projects.
  
• Providing cost controls for the customer.
  
• Creating control of project life cycle.

If project management is executed properly, it transcends project management and becomes relationship management, because the contractor has successfully performed as a partner. This, perhaps, is the true goal. As an outsourcing customer, you have to be comfortable with your contractor, with their delivery and their company structure. You have to know they care about their customers. The best way to show this is by delivering projects on time and within budget—and to the highest quality possible.

Ronald A. Malone is Senior Project Manager at SP Pharmaceuticals

For more information: Arthur C. Solomon, Vice President of Business Development, SP Pharmaceuticals, 4272 Balloon Park Road NE, Albuquerque, NM 87109. Tel: 505-761-9230. Fax: 505-761-9229.

Visit SP Pharmaceuticals' Storefront on Pharmaceutical Online.