Best Practices in API R&D

The Secret Sauce Revealed

Posted: January 21, 2019

API Manufacturing and Pharmaceutical Manufacturing

It isn’t all that often that a sponsor can go to a CDMO with the expectation that the R&D team that begins their API development project will be the same team through the entire R&D and scale-up process.  Yet one of the most important aspects of the chemistry involved in an API development project is the chemistry between members of the CDMO’s team as it works through the development of new molecules. 

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Why is having the same team so critically important to sponsors? Because it can be disruptive to have your chemist leave during a project. It can also be expensive because a replacement chemist needs additional time to get up to speed.  Those who have experienced the upheaval it can cause know it can be a very unpleasant experience.

That’s why the number one best practice in R&D is staff retention, something we take great pride in here at SEQENS North America (formerly PCI Synthesis).  This article will focus on what we do to have a remarkably low turnover in staff, which is so unusual in the industry.

There are several reasons people stay with us despite the highly competitive climate for Ph.D.’s in our area. The chemistry Ph.D.’s who are the backbone of all CDMO organizations are looking for three things:

  1. A place to work where they are technically challenged.
  2. A competitive salary.
  3. A work environment where they feel appreciated and supported. 

These are commonplace goals, but difficult to achieve. Here’s how to build a successful R&D operation.

Varied technical challenges result in interesting work

The numerous large and small drug developers in our area, as well as our international clientele, provides us with a customer base with a large variety of innovative development projects of tremendous complexity. As a result, our R&D teams are technically challenged to find unique solutions, making their daily work intellectually stimulating and the results enormously satisfying.

Compensation

We make sure our R&D team members are well compensated from the start and that they have ample opportunity to advance quickly as their knowledge and experience grows.  However, it’s the interesting work and the satisfaction of knowing they are working on tomorrow’s new therapeutics that are  the more motivating factors.

In that same vein, I recently saw a survey that the most highly skilled engineers and programmers in Silicon Valley take lower salaries and even pay cuts to work at electric car manufacturer Tesla rather than Apple or Google, where they can command higher pay, because they want to be part of ushering in tomorrow’s technology.  We are ushering in tomorrow’s drugs, pushing forward the frontiers of increasingly complex science and paying very competitive salaries –  a winning combination. That’s been tremendously successful for us, and we find it gratifying to bring someone in at a good starting salary and see that person’s salary double in just a few short years.

The organization structure that works best for R&D

Decades of experience have taught us that the typical CDMO organizational structure—Director, Group Leaders who oversee a couple of chemists on a couple of projects—is too regimented and hierarchical for R&D teams to function optimally.  We are unique in that we decided a long time ago that structure doesn’t work well within our R&D organization.

There are several reasons for this.  Chief among them is that chemists are well aware of where their colleagues trained, what they’ve published, and who mentored them.  They wear these badges of honor openly. In some cases, whether appropriately or not, they may decide that they report to people less qualified than they are. This can lead to disgruntled workers who start to look for other opportunities.  That is rarely an issue in a flat organizational structure

Producing leaders by design

We want our R&D chemists to step up and take leadership. We encourage them to teach others.  We encourage them to take control, make decisions, take a lead on a project if they are the best person to do so.

Our chemists stay with us because every team member is involved in the project’s technical work, sharing know-how and ideas. Leadership rotates with learning. Technical support is always available to all projects from Rajesh Shukla, our Vice President of R&D, who has been with the organization for 15 years and is available to all R&D teams.

The flat organization structure with team members empowered to make decisions and getting guidance when they ask for it not only makes us a great place to work but is ultimately very productive.

Who to recruit and how to train

Another very successful strategy we employ is to recruit post-docs from academia and industry rather than hire people who have worked at other CDMOs or big pharma. Why? With post-docs we have the opportunity to train and ingrain an innovation culture rather than hire people who have become set in their way or someone else’s way of doing things.  The latter doesn’t work so well at a CDMO like ours that is constantly developing new chemistry or finding new uses for chemistry we have previously developed.

As a result of our hiring practices, which include networking with people we know and trust, we have rarely had to let anyone go.

Our training is not particularly formal. We train our chemists in our way of doing business and in how we operate by getting them involved in projects. We train less on technical aspects of the job and more on our culture, expectations, and most importantly, how to interact with our customers. 

Which brings us to four other R&D team best practices that we employ throughout the organization, briefly summarized as we have written about them in greater detail previously:

  1. Constant and open communication with our customers. We work on very complex problems. With so many unknowns, we do not want our customers to be surprised, and insist on reviewing work with them on a regular basis—what’s going smoothly, what isn’t.  We take great pains to make sure our customers never feel taken advantage of.  If an amendment is needed, they understand why and can make an informed decision.
  2. To assure we are using the best chemistry available, we have many internal discussions. We check the literature. And we draw on the vast experience of our team to assure that the process being developed is the most scientifically sound.
  3. We involve analytics early on.  Once rough methods are developed for the project, we get the analytical team involved in determining the extent of impurities and developing the analytical methods. It is a highly efficient way of being able to release material as soon as possible.
  4. Finally, we insist on kilo lab scale-up. The investment in process optimization is a tremendous project cost-saver. 

For more about our approach, check out our articles about how to select a CMO, part I and part 2 or What Does It Take to be a Good Project Manager for Drug Substance Development? Or call us at (978) 462-5555.

About the Author

Ed Price CEO of PCI Synthesis
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). 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.