5 Important Things to Look For in Your CMO’s Project Management Capabilities


When looking for a Contract Manufacturing Organization (CMO), sponsors naturally look for CMO attributes such as quality, reliability, productivity, affordability, innovation and regulatory history.  But in evaluating a CMO, an often overlooked but important differentiator is skilled project management. Ignore that at your peril.

The project manager is not only the person you, the sponsor, will spend the most time with at a CMO, but also the point person who will need to be relied upon when issues arise–and they will. This article provides some insights regarding Project Managers and questions to ask a prospective Project Manager at a CMO you’re considering.

As we’ve detailed in Successful API Development: Lessons from a CMO, it’s not unusual to encounter problems in developing new chemistry. There could be an issue with analytics, the chemistry may not be working well, the needed raw materials don’t arrive as scheduled, or they arrive but are of poor quality.  It’s not unheard of for these problems to occur simultaneously.  An unflappable, experienced project manager knows how to deal with these things and will have a Plan B, Plan C, and even a Plan D for keeping the project on time and on budget.

The Indiana Jones of a CMO

Think Julie Andrews’ Maria in The Sound of Music. Confronted with seven children and a looming war, she deftly navigates as the world around her implodes. Or Harrison Ford’s Indiana Jones, charging through obstacles and vanquishing villains with the end goal, the arc, firmly and always in sight. And good with a whip too.

Such is the derring-do life of a Project Manager.  Except, unlike Jones, our Project Managers follow rules.

That’s why at PCI Synthesis we revere our project managers.  They can handle pressure. They are problem solvers. They work their magic to rework things if they are not going as well as they could. They make sure their project team has everything they need when they need it. Consummate multitaskers, they pursue all options with one goal in mind: keeping projects on time and on budget. And they know I’ll be on their case if a project falls behind.

Therefore, when selecting a CMO, take a good hard close look at the project manager. No matter how well the technical and manufacturing aspects of the project end up, poor project management can turn a great project into a highly difficult and negative experience.

Project management evolves

Over the past ten years PCI Synthesis’s project management systems and capabilities have continuously evolved, much of it as a result of feedback from the great variety of customers we serve and the many different types of projects we’re completed.  We always learn something from each and every project and implement new ideas all the time.

Project Manager: the 5 most important questions to ask

When evaluating the Project Manager who is going to oversee your project, there are certain things you need to know and be assured of.  These are the five most important questions to ask.

  1. Is the Project Manager assigned to your project reliable?

You need to be sure the person running your project follows through and tracks action items.  A good record of each meeting is critical for managing expectations and keeping everyone on the same page.  Ask your CMO to allow you to speak to other sponsors who have interacted with this Project Manager. Consider any hesitation by the CMO as a big red flag.

  1. Is the Project Manager knowledgeable?

The project manager is not a scientist and does not necessarily need to be knowledgeable about the chemistry or the analytics – that’s not their job. That’s the job of the scientists.  What the Project Manager needs to do is present well, have a basic knowledge of the business, the industry and how all the different aspects work together.

When you interview the proposed Project Manager, remember that you will most likely interact with this individual more than with anyone else on the project team. Make sure you feel comfortable during the interview. If he or she happens to have more knowledge and experience than you do, consider that a good thing! As you know, when you have a good relationship, the Project Manager will advocate for you behind the scenes when it’s most important.

Learn how to accelerate your API manufacturing project »
  1. Is the Project Manager a personable leader?

Can you visualize this person managing a 10 to 12 person team and getting results? In order to be a good leader, you need to hold people accountable on both the sponsor and CMO sides.

A winning personality is the key for an effective Project Manager. That person needs to be able to rally the team and push them to help meet the goals and deliverables of the project. Your Project Manager needs to be able to deliver any kind of news, good or bad.  When there’s a snag, the Project Manager also needs the foresight to present various options or ways to bring the project back in line.

Bottom line: good Project Managers don’t just tell you what the issues are with a smile on their face. They present solutions with the goal of keeping the project on time, within budget and one that ends up with an excellent, high quality product.

  1. Does the Project Manager assigned to your project have the tools to drive a successful project?
  • Is the Project Manager a good communicator?
  • How will you receive updates?
  • Do you have a safe and secure means of sharing and storing documents?
  • Is there a good system in place to deal with out of scope items and project amendments?
  • How will you be updated on the budget and timeline? How often?

A good Project Manager will be sure to keep the lines of communication open, have weekly or bi-weekly meetings and have a location where you can safely share documents. The project is going to be difficult enough. The Project Manager should have tools in place that make it easy for everyone to clearly understand where things stand in real time. There should be no surprises.

  1. Is your Project Manager a critical decision maker with the authority to make decisions?

It is important to have a Project Manager that is broad minded, can think about the projects technical aspects, budgeting, and have problem solving skills. A good Project Manager needs to be ready for anything.

Ask whether the Project Manager has the authority within the CMO to make decisions and hold people accountable.  If decision-making in the particular CMO is centralized and the Project Manager constantly has to “check with management” before making decisions, it could slow the project down unnecessarily.

As well, time management skills are essential for a Project Manager whose job it is to keep the team motivated every day so timelines are met.


When choosing a CMO, don’t overlook the Project Manager, who is a critically important member of the team. That person needs to be able to multitask and wear several different hats.  Personable and with strong leadership skills for managing both the internal team and the sponsor’s team, a good Project Manager can rally the troops to work together and achieve the ultimate goal of meeting the project plan, budget and the overall expectations. It may take a little extra effort but a little due diligence up front to making sure you have the right team to tackle your program will make everything easier and smoother as the engagement proceeds.