What Does It Take to be a Good Project Manager for Drug Substance Development?


Every field requires good project management to ensure projects run smoothly, but perhaps nowhere is it more critical than in pharmaceutical development.

Bringing a quality new product to the market safely and quickly is how pharmaceutical firms achieve success, and how Contract Manufacturing Organizations (CMOs) continue to be hired. Yet, both sides – sponsors and CMOs – can encounter enormous challenges during the long product-development process.

Nothing is guaranteed in the complex manufacturing process, and often, the best-laid plans need to be changed because of the nature of working with chemicals. However, if the risks associated with the uncertainties are not managed in a timely and effective manner, the complexity of the situation increases dramatically and it subsequently becomes a longer, costlier project. Because of this, projects managers play a critical role. They’re responsible for managing the teams, communicating with sponsors, and making sure projects stay on track and on time, within all key business processes, such as chemical development, quality control, regulatory strategy and even final packaging.

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The Role of Project Management

So what are some of the key responsibilities of a CMO-based project manager?

Scope management. At the very outset, a project manager must work with the sponsor to specifically outline the goals of the project, assign the team members, including the technical team and the analytics team. It’s important that the sponsoring organization has parallel staff responsible for these same areas. Often it might be the same person handling several of these roles on the sponsor side, but it’s important that each role has experts working in tandem to move the project along.

Project planning and monitoring. The project manager also develops a scope of work, spelling out, for example, how many kilos are required and when they need to be delivered. He would then move backward, identifying all the activities that need to take place, such as sourcing raw materials, analytical development, etc., to meet the end-goal. This would all be contained in a Gantt chart identifying a timeline, as well as a budget.

Stakeholder management. In addition to managing the scope and budget of the program, the CMO’s project manager also must be the primary contact for the sponsoring organization. It’s the job of the project manager to regularly update the sponsor, holding regularly scheduled meetings (we recommend weekly conference calls) with them and sharing key milestones of the project. Not the most favorite part of the job, but it’s also the project manager’s responsibility to notify the sponsor when projects run into problems that would impact the timeline and budget.

Management of regulatory and compliance strategies.  The project manager also works with the QA team to make sure the project is in compliance with FDA, GMP and other guidelines, and that the information is clearly documented.

Team management. Finally, project managers work with the entire project team to make sure deadlines are being met and the project is moving along as planned.

What Does It Take To Be a Good Project Manager?

As you can see, project management is no easy task in contract manufacturing. While many in the industry may think that having a chemist with a Ph.D. and extensive scientific experience is what they want to see in a project manager, that’s not always the case.  A good project manager needs to be a good business person, as well. Often, a chemist with little business background can get so caught up in the details of the chemistry that he/she fails to see the big picture. The project manager must be able to keep people accountable and understand how to manage a business and deliver a product.

Another skill of good project managers is communication.  They must work closely with other project managers in the business to understand the interdependencies within the project, understand resource conflicts, and take action accordingly. Making team members aware of their roles and responsibilities during the planning stage can help prevent confusion in the later stages. A good project manager must keep the team enthusiastic by helping them understand the importance of their contribution.

In addition to the internal team, good project managers must develop strong relationships with their counterparts from the sponsoring firm. Aside from regular meetings and contact, keeping sponsors informed through every stage of the project helps to minimize surprises when things go wrong that may require additional budget and resources. When the sponsor is truly part of the team and intricately involved in the project, they understand how problems can arise beyond anyone’s control and can share that information with their senior management.

The project manager plays a critical role in creating a CMO environment that is conducive to a project’s success. By clearly defining the goals, roles and responsibilities, and fostering open communication and accountability among stakeholders and team members, good projects managers are like musical conductors, bringing all the parts together to create a masterpiece.

For other articles on CMO best practices, check out Controlling Impurities In Drug Manufacturing, API Quality Risk Management, or Top Early Stage Method Validation Mistakes and How to Avoid Them. Or please call us at (978) 462-5555.