We gathered four process development scientists and directors at early and mid-senior stages of their careers to tell us more about the opportunities for scientists and engineers in process development, their day to day responsibilities, and their best advice for moving into this field. Here is what they had to say.

The Four Panelists.

What is process development?

Yonatan Lipsitz, Director, Process Development - Sana Biotech

The nuances of process development as opposed to basic research are twofold. One is scale up, how can you actually turn this into a medicine and actually make it. 

Another is how can you do it reliably? In basic research, you do the experiment and it works some fraction of times and then you can write it up in a paper. But when you're actually making a medicine, it has to work every time. So exactly how to do it has to be described well enough that you can get someone in a manufacturing facility to do it for you and to do it correctly every single time, such that you have confidence to eventually safely put that product into a person.

What does your typical day look like? 

Sreya Bose, Scientist - Lonza

My typical day looks very similar to what a PhD students or a postdoc’s day looks like. There’s gonna be weeks which are very experiment and lab heavy because I'm developing a process. I'm optimizing the process and I have to be in the lab executing the activities. 

But some weeks are very paperwork heavy. Maybe I'm working on the protocol for the process or maybe I'm working on a report with the data that was generated or I'm working on data analysis.  So the science part of it is very similar, at least for all the entry level people who are entering into process development. 

Of course, there is the aspect of client interaction. So I work in a contract manufacturing and development organization (CDMO). So I'm interacting with clients who are utilizing Lonza’s services to help transfer their products to a commercial scale or manufacturing it at a larger scale. I'm also interacting with the other departments because I will develop the process but it has to be transferred to manufacturing. That might also involve training people. 

And as you keep moving up the ladder in process development, sometimes you might also help the client with their IND filings and different kinds of regulatory applications. 

What Technical Skills are important for Process Development

Yonatan Lipsitz, Director, Process Development - Sana Biotech

The technical skills in process development are actually very important when I review resumes. Anyone who has never run a bioreactor, never run a shake flask, never run various assays for downstream purification, it's pretty hard to get your resume past that first screen. Someone who receives your CV is gonna say, “I'm gonna have to train you on the very basis of what your job is.” You're a less competitive candidate. 

Also, familiarize yourself with statistical design of experiments. A candidate who can tell me, “this is how I would design an experiment to have the statistical power to get a certain readout, and these are the statistical tests.” gets extra credits on the process development side. It often is seen to differentiate you from being a biologist who may not use those types of statistical methodologies. So familiarize yourself with statistical design of experiments. 

Sreya Bose, Scientist - Lonza

At least in Lonza, whenever we hire process development roles we also need very strong assay development skills because it is not just the process part of it, but also making sure that whatever came out from the process has gone through these assays and the assays have validated that the product that was generated is good. This is where a lot of my colleagues who have more molecular biology heavy skills find positions.  

What soft skills will help you succeed in Process Development?

Alireza Abazari, Director of Process Development - Pluristyx

Because of all the interactions you have to have with other teams and other people, your technical expertise would be only about half of your required skills. The rest of your delivery and efficiency at work comes down to how well you manage your relationships with the other departments, with the other people in your team, how well you communicate, and how open minded you are to changing things that you've learned. 

Yonatan Lipsitz, Director, Process Development - Sana Biotech

I think communication skills are a better predictor of success than technical knowledge. Certainly you do need the technical knowledge to succeed, but where people struggle, it's almost always in communication.  They can't get their ideas across, they can't get people on board with what they're doing. That's where I've seen the most failures in people who get into industry. Certainly you meet people who don't have the technical skill set, but that's much less common. 

Is a Postdoc Necessary?

Sreya Bose, Scientist - Lonza

It's very situation dependent. So the reason I did my postdoc is that my PhD was in plants. I had not done human related or animal related things. So I needed those skills. That understanding of what I needed to make my next transition led to a very conscious choice for me that I wanted to do a postdoc, specifically to gain a skill set. But I know many of my colleagues, they come fresh out of their PhD and they have started their job in the industry because they have exactly those skill sets that were required for their job. 

Kevin Wang, Senior Scientist/Group Lead, Process Development, Vertex Pharmaceuticals

Right now I am mainly working on bioreactor scale up. And I did not have experience on the reactor during my PhD. So my skill set and experience in developing this process is mainly from industry. And actually, I think most of my colleagues, they also got those experiences from industry rather than in the academic world. 

How to gain the right skills to advance?

Yonatan Lipsitz, Director, Process Development - Sana Biotech

Get hands on experience while in school in the techniques you want a job in. If you want to work in process development, work on a project that uses some of those pieces of equipment. If your lab doesn't have them, set up a collaboration with a lab that does, and learn them. You can also get an internship. Either during your studies or even right afterwards. Many internships turn into full time hires, it is almost like a "probation" period

Alireza Abazari, Director of Process Development - Pluristyx

We are in a day and age, fortunately or unfortunately, that nothing is going to be constant for more than a few months or a few years. Everything changes. 

People move on and these provide opportunities. Sometimes, you're working on a team and they ask you to take on a new role or research area, don’t be afraid of jumping into new challenges when the opportunity arises and gives you the chance to upskill or expand your knowledge as part of your work. 

Kevin Wang, Senior Scientist/Group Lead, Process Development, Vertex Pharmaceuticals

Most companies do have programs to help you grow. For example, for me, I communicated with my manager that I wanted to move up to a people manager. I was able to do some work, demonstrate my capability and right now I have a team. So, I think it is very important to have a goal and also to communicate your goal with your manager and deliver your work. 

Thank you to our panelists for taking the time to share their experiences with us.

You can view the full conversation with our panelists here.

If you would like to find out what kind of industry roles your skills make you a good candidate for, please create a profile on Scismic.com/scientists.