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How to Become a Process Development Scientist

Faculty Insights Industry Advice Science & Mathematics

Jared Auclair, Northeastern University’s director of Executive Training and Biotechnology Programs and director of Northeastern’s Biopharmaceutical Analysis Training Lab, shares his advice on pursuing a career as a process development scientist. 

In the biopharmaceutical field, especially when it comes to biosimilars, it is said that “the process is the product”. Thus, a process development scientist is critical to the production of important protein drugs. As crucial as the role is, however, not many professionals consider this career path as they enter college or the workforce. Rather, it’s a career many “fall into.” Although it would seem, then, that there is no direct path to be a process development scientist, this is not the case. Over recent years, the path to becoming a process development scientist is becoming clearer, protein drugs are becoming more commonplace in industry and demand has increased exponentially.

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What Does A Process Development Scientist Do, Anyway? 

The role of a process development scientist differs significantly depending on the field, including within the sciences. A process development scientist in biotechnology most often deals with the production of protein drugs from living biological systems both on small and large scales. Pulling from theories in engineering and life science, the professionals in this discipline also focus on scaling drug compounds to mass production while remaining compliant with strict regulatory policies.

What Skills & Education Do I Need to Become a Process Development Scientist? 

Educational science background

Like most jobs, a diverse set of skills is needed. To succeed as a process development scientist, an understanding of biology and chemistry is needed in order to manipulate cells and processes to optimize the production of the end product. These roles also require knowledge of the general principles of engineering, as these fundamentals are critical in any scale-up process and the large-scale production of drug products. In terms of formal education, these roles rarely require a PhD, but a master’s or bachelor’s degree in any of the above topical areas will suffice.

Hands-on experience

In addition to traditional training or education in biology, chemistry, and engineering, it is also crucial to have hands-on, practical experience. This is particularly difficult to do in an academic environment, as most academic labs focus on research, rather than process development training. It can be done, however. To get this necessary hands-on experience, one must find a degree program that offers a form of experiential learning or otherwise look outside of academia to the industry. Beneficial hands-on training can include working under the tutelage of a process development scientist, actually performing the job itself (preferable), or it could simply include shadowing someone.  In any event, the more exposure one has the more successful one will be in pursuing this profession.

Project management skills

Many aspects of a process development scientist’s role require project management skills. These scientists must be extremely organized and methodical to ensure processes are functioning properly, and if they aren’t, they often must be adapted, and on the fly. Keeping detailed records of each step of the process throughout each round of the process is paramount to patient safety. As a process development scientist, it is also helpful to have an investigative nature, analytical mindset, problem-solving focus, and a methodical approach to testing new processes.

Ability to work on a cross-functional team

To be a successful process development scientist, you must be able to perform on a cross-functional team. This is often a bigger challenge in a process development role as opposed to a traditional biotechnology job, as you must be able to speak the language of an engineer and biologist, or even represent both aspects. The ability to work across disciplines even more crucial with the “Quality by Design” movement occurring in the drug development field.  Thus, to pursue a process development scientist role one must be technically proficient as well as able to manage a team and complex systems.

With the right skills and knowledge, a process development career can be lucrative and rewarding. To learn more about this and other career opportunities in the biotechnology industry, download our guide below.

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