Abstract
To ensure reliable delivery and optimize outsourcing costs, it is essential to partner with a contract manufacturing organization
(CMO) that uses multidimensional strategies. Older models of project management were not focused on client satisfaction and
did not account for the organization's needs. More recent models in project management blend and integrate these objectives.
They leverage best practices from different arenas to integrate the needs of the client, project, and business. This article
presents a model for conducting work based on three core methodologies: project management principles, customer service, and
Lean methodologies.
Baxter International
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In this troubled economy, fewer companies are manufacturing their pharmaceutical products in-house.1 More and more companies are working with contract manufacturing organizations (CMOs), or are actively looking for CMOs to
partner with. To ensure reliable delivery and optimize outsourcing costs, it is critical that your CMO relationship yields
the best possible value to your organization. To achieve optimal results from your outsourcing, it is essential to partner
with a company that uses multidimensional strategies, integrating best practices from project management, customer service,
and Lean methodologies.
A CMO worth spending your money on must do more than just produce your product. It must serve as an expert partner to help
maximize your product's potential. Like any customer, you want the CMO to treat your project with care and commitment. Older
models of project management were not focused on client satisfaction, and did not account for the organization's needs. More
recent models in project management blend and integrate these objectives. They leverage best practices from different arenas
to integrate the needs of the client, project and business. Blending best practices from project management, customer service,
and Lean can provide optimal results for clients.
The Role of Project Managers
The role of a project manager at a CMO has evolved to encompass a broader set of stakeholder expectations, including delivering
excellent customer service and driving leaner processes. Traditional project management models focused on the success of the
project only in terms of the constraints of time, scope, and quality. Today's project managers must deal with increasing complexity
and offer their stakeholders the optimal strategy for the project. A systems approach is essential to identify and manage
all constraints. Additional metrics must be created and monitored, such as customer satisfaction surveys and measures of process
efficiency. When selecting a CMO, consider how facile their project managers are at analyzing tradeoffs among the constraints.
Do they have tools and processes in place to provide you with this critical information? If you are considering a process
change, will it mean that you won't be able to operate as efficiently down the road? When problems arise, will the project
manager address them within the organization, or will they inform you and include you in the resolution process?
Project Management Principles
Not only are biopharmaceutical companies looking for state-of-the-art facilities, reliable quality systems, and technical
know-how, they also are looking for CMOs that will manage their projects well. Biopharmaceutical companies must look for CMOs
that deploy repeatable project management best practices and processes to drive down project cycle time. They also should
look for CMOs that work toward eliminating the "accidental" project manager assignment through training, coaching, and mentoring.
This includes development and use of tools, templates, and checklists, as well as establishing metrics to measure performance
and risk. Project management certification is one means of assessing an organization's dedication to effective project management.
Although certification is not a guarantee of effective project management, it is a positive indicator of organizational commitment
to project management knowledge and skills.
