CMC, Chemistry, Manufacturing and Controls (CMC) refers to all the elements involved in producing pharmaceutical, biologic, or cell & gene products. CMC activities commence from product development and progress through pre-clinical, clinical, and eventual marketing. Various skilled professionals work in CMC to develop and manufacture safe and compliant products including GMP, analytical scientists, process scientists, regulatory, and quality. All these specialisms require careful career planning to ensure professionals excel. 

Educo Life Sciences spoke to our expert trainer Raz Eliav, who provided useful tips for progressing through your CMC career. You can watch or read the interview below.

For people new to this industry, what is CMC development and why is it important?

First of all, development implies that we’re talking about drug development, so we are sort of, in the years where we are, actually doing the effort of finding new drugs and proving that they’re safe and effective as opposed to, speaking of, you know, the pharma industry as a whole where we have, a whole lot of other people working on, on commercial drugs in the pharmacy that we all know very well.

So, the field of drug development is about finding those new drugs, and what usually gets most of the attention is clinical development. So, we all know about clinical trials, and animal studies that precede them, where we basically, prove that this new potential drug is safe and effective. But what usually happens behind the scenes is that, we need to somehow, manufacture this drug, and as we all know, and take it for granted, drugs are very high quality. So, when you buy a pill in the pharmacy, you take it for granted that it’s safe for you, or at least that you know what side effects to expect. You know what it’s going to do, its intended effect, and you trust that no matter when you buy it, you know, that it’s more or less the same thing.

We take that for granted, but what happens, behind the scenes, is that it takes many years to develop the manufacturing process of a drug and the way we control its quality, and that is what we call CMC development. So basically, as the project begins, even as early as the first animal studies, we already start, establishing this manufacturing process and controlling the high quality that we’re expecting of this drug because that will basically be the basis for us later on to commercially manufacture this drug and, produce it for market supply. So, CMC development, in essence, is this parallel track to clinical development where people are in charge of developing the manufacturing process and also to provide material for those, clinical trials that I mentioned.

For people starting in CMC development, what challenges are they likely to face?

So first, we must understand that very few people work in CMC development. It’s usually some way or another, an entry-level job in this field. So it could be that you work in a QC lab in quality controls or it could be that you’re on the manufacturing floor of a company that makes a drug, or it could be that you’re a scientist in a development team, but it’s never, the title CMC is a bit, vague to many people because CMC is an umbrella term that covers many different aspects and many potential career paths and jobs, a bit higher up, so when we look at second and third jobs, then you do see more titles that bear the word CMC.

As individuals embark on their careers in the CMC (Chemistry, Manufacturing, and Controls) sector, they typically commence their professional journey in entry-level roles. An eminent challenge encountered is the substantial disparity between the knowledge acquired during academic pursuits, often within the realms of life sciences, chemistry, or engineering, and the practical expertise requisite in the industry. Despite the comprehensive understanding of fundamental principles and concepts, the transition into the industry engenders a sensation akin to grappling with an entirely new lexicon from day one.

Everyone is throwing different acronyms at you, I’d never heard the word CMC before I went into the industry and many of the topics that are the day-to-day of the pharma industry and of drug development are not directly, relevant or touched in your university studies, so you enter this place, everything is very fast-paced, especially if you work in a startup. But even if you’re working in a bigger company, things usually move very fast, and your colleagues are usually quite busy, so they’re probably not going to be able to sit down and teach you properly whatever there is to know, so what happens to most people is that they just learn by doing. It’s a great way to learn, I learnt this way, and everyone will continue to learn this way no matter what we do. But I think that the lack of having the big picture in mind and understanding how the dots connect, just makes it a bit more challenging to sort of go through the day-to-day activities. So yeah, I would say those are the main challenges, but of course, there are probably many more.

What advice would you give to people starting in CMC development to be successful in their role?

First and foremost, be ready to learn and learn a lot. If you thought that your studies end when you finish university, and I hope that it’s not a disappointment for you, but you will continue to learn, the learning curve is just going up now, and there are many new things that you will learn, by the way, not only because you’re new to the industry, but simply because you are new to this project that you just landed. So if it’s your first job or even your second or third job, or actually at any point in your career, whenever you land a new project, it’s going to be a new type of product, a new group of people, a new company, a different stage of development. As I mentioned before, clinical development can take, 10, to 15 years sometimes and each stage of the way looks different, so you rarely land in the same situation twice, you must be ready for a career that is very intensive in learning all the time.

As I said before, I think that for me at least, the most helpful thing is to try and see the big picture so even if I’m joining a project as just a tiny ant, you know, moving my piece of sand from one place to the other, investing the first few days, weeks, to sort of see the big picture, talk with people from other departments, read about the company, read about the drug, read literature, you know, just, be as wholesome as possible with your understanding, not only of your specific focus area, that would make you, first of all, much more passionate about what you do, so you understand what your tiny piece means, with this big puzzle, and it’s going to also make you a much more valuable team member because, you know, we’re all smart people, and we can always contribute to other people with our unique perspective, so I think that seeing the big picture, and at least trying is, very helpful.

Now a bit more, let’s say, focused advice would be to look up some newsletters in the field or there is a lot of content and material that speaks more generally about different aspects of our industry, so make yourself a habit of reading those newsletters. Maybe I should have said it first, but there are the regulatory guidelines, and the regulatory authorities that are involved in this entire story, they publish huge amounts of content, to teach the industry what they’re expecting of them. I’m not talking about reading the actual, code of law, which is very difficult and vague to understand. The FDA, the European authorities, and almost all authorities publish guidelines written in the native language that are usually easy to understand. You don’t always understand the full thing especially if you’re just starting, but just getting the gist of what’s going on and what is the regulatory framework, is very helpful again, for you to connect the dots with your piece of the story. So, look up FDA guidelines, ICH, ICH is a very important source of guidelines to read, you know, make a habit of just reading, let’s say, one guideline a week and after your first year you will be very, very, well, educated.

Of course, you can follow professionals, on LinkedIn, many people, myself included, regularly post, content, reflections, advice, bringing up new guidelines and just coming up with short commentaries, so it’s really useful to expand your network of professionals and that you follow their content on LinkedIn, and that’s also part of your learning habit. I would say that’s general career advice, it works for anything that you do in life, but pharma is no different. Just make yourself valuable to whatever job you land, do 10% more than what you’re expected to do, learn things outside of your immediate scope of work, today there are so many resources out there that there is no excuse for not doing it.

I would say last, especially if we’re talking with people at the beginning of their career, they hold the advantage of being very natural with technology. I’m not that old, but I’m old enough to have, grown up with less technology than today and I think that people who are graduating today have already used their semi-professional life, during university, some of the advanced tools today, obviously ChatGPT and other labs and even just computer literacy in general is much, much higher, for the younger generations. So, I think that harnessing these advanced tools in creative ways and moving forward in the digital revolution, you might think that it’s all top down, you would enter a company and they would present to you their digital tools, but you’d be surprised how far behind pharma is with regards to adopting digital technologies and, what we see in many places is that the transition is happening bottom up, people bring their digital skills, their digital capabilities and that’s part of what I said of becoming, a more useful team member is that you can bring in new spirits and new tools to improve everyone’s lives.

What are some of the most difficult aspects when working in CMC development?

Many people arrived in the industry after having graduated from, sometimes very advanced careers, even, PhD studies. So, we’re talking about people that have been in the academy for many years, some of them have publications, they are used to public speaking and going to conferences and being relatively important in what they do and feeling a lot of sense of meaning in their day-to-day life. Then, they suddenly find themselves in an entry-level job in the industry, sometimes they’re low-paying, and very hard. It could be working shifts, or it could be, again, very fast-paced, very different from their academic life. So, for many, it’s a culture shock to the point that they run away, they’re like, okay, pharma is terrible, I don’t want to work there, because again, it’s hard to see the big picture in that day to day when you have an assignment to, I don’t know, run 15 experiments of almost the same thing for two weeks now and then having to sit down and writing reports with templates and just filling in Excel sheets. And a lot of the aspects, especially early on, but also later on, are mundane and technical and grey, and yeah, some people come from the academy with some fatigue from hands-on work, so they swear they don’t want to touch, a pipette ever again, and they think that working with the computer is much more fun, but then they find that you know, it can also be mundane and sitting all day long after being used to, working with your hands is challenge to adapt.

And sometimes the opposite, by the way, some people are so passionate about their hands-on work that they never want to stop doing that but then they realise that even if they find hands-on work, they still have many other things to do. They, need to fill out forms and results and sign and review things, and you’re inevitably entering a very different mindset from what you had in the academy, it’s a shift and it’s a challenge to sometimes shift gears. But again, I think it’s helpful to see the big picture, to understand where this career path is taking you, so maybe you’re facing now 2 or 3 years of a slightly less interesting job, but hey, the experience you will gain, the knowledge that you will gain here will be very valuable in that thing you want to do, later down the road. So, it’s worth hanging on in these difficult years because I think that there are a lot of very exciting things to do in the industry.

How will your course, CMC Essentials: An Overview of CMC Development help delegates be successful in their CMC careers?

The CMC Essentials training course was built with people at the beginning of their career path in mind. So, the idea is to, on one hand, teach the basic language and know what there is to know, so to speak. But the special thing about the CMC Essentials training course is that it’s a very wide overview. So, whatever it is that you’re doing in your first role or what you’re intending to do, it’s probably going to be just a small part of the course, and really what we’re going to do is to touch upon all the topics in CMC from beginning to end, without going too much into detail.

The intention is to give you a broad overview to work more on the connections between things and the language that you will encounter eventually. So, you would sit in a group meeting, and you are part of the quality controls team, and you would hear things from the process engineers and have a better understanding of what they’re doing and what their life is about.

Again, this connects back to seeing the big picture and becoming a more useful team member, it’s always good to know what the person from across the hall is doing, and this will help you understand what there is to know, what questions to ask, what is relevant in your work to them. As a side effect, you would also probably be able to better decide what you want to do when you grow up in the field. We all start somewhere in a tiny spot and we don’t know exactly where our career is headed, so by understanding what other people do, we might find out that yes, there is this thing I’m probably going to be passionate about, and even if I’m not there today, I at least know where to direct my effort, where to direct my curiosity, where to direct my next career moves so that in five, ten years from now, I will be in the point that I’m most passionate about. The industry is so diverse everyone can find their sweet spot doing what they love most be it, hands-on work or more language work or knowledge work. It’s diverse. We do many, many different things and there are many different options for different kinds of people.

Watch the interview below: