This article was originally published in the September-October 2017 issue of Pharmaceutical Engineering® magazine. Missed part one? Catch up now – The Engineer's Role in the Biopharmaceutical Supply Chain – Part 1. Get part three delivered straight to your inbox by subscribing to iSpeak.
To shed light on the role of engineers in biopharmaceutical manufacturing, this article presents three "virtual roundtables" featuring engineers that work in each of these positions.
Roundtable #1—Process Engineers: Revolutionizing Operational Opportunity
Engineers focused on process engineering and process development are responsible for the conceptual design and optimization of new operations, taking a product from bench-scale to full-capacity production using the most efficient means possible. Equipped with a blend of scientific, technical, and engineering expertise, these specialists must understand how a specific process fits within an organization’s large-scale production plans. Process engineers boast a skill set that’s sought after by both large and small organizations, as well as contract development and manufacturing organizations and consulting firms. Indeed, most have a bachelor’s degree and several years of industry experience. As is evident from the discussion below, process engineers possess, above all, a lifelong passion for continual learning that allows them to keep up with modern technologies and trends.
Participating in this discussion:
Can you tell us about your job?
BERNAL: As a field-based process development scientist, I proactively pursue and perform process-development studies for the purification of antibodies, vaccines, viral vectors, and all kinds of therapeutic proteins; I provide technical support as well as drive technical collaborations between MilliporeSigma and the client.
HYDOCK: As part of the integrated solutions team, I develop and implement rapid and cost-effective solutions from early-phase development through scale-up to commercial manufacturing. This includes close collaboration with customers and other preferred solution providers to consult on conceptual designs and process capabilities and to provide implementation support for hybrid and single-use equipment and services.
PECK: In representing a manufacturing company, my role is a little different from Oscar’s and Marisol’s. I track current batch performance, troubleshoot issues, and analyze fermentation data to drive improvements, make recommendations to management to secure buy-in, and complete projects.
Which emerging technologies and trends are interesting to you professionally?
BERNAL: As the scale of titers is increasing and pushing the limits of older purification technologies, I am seeing a lot of interest in single-use technologies and continuous bioprocessing.
HYDOCK: Cell and gene therapy, full implementation of single-use and continuous bioprocessing. We help growing companies realize that single use is a very robust solution for them—with the knowledge that no single solution fits every process.
PECK: I am very interested in using automation to measure many points across a process and having that information converted to a specific action.
What has been your career trajectory?
BERNAL: I completed my bachelor’s degree in chemical engineering and microbiology in Colombia, and then came to the United States for my doctorate in chemical engineering. I spent a year doing chromatography process development on flu vaccines and then transitioned to my current role as a purification Subject Matter Expert covering Southern California at MilliporeSigma.
HYDOCK: While in school, I interned in quality control for a solid-oral-dosage facility. After graduation, I was hired as a bioprocess technician at a start-up vaccine manufacturing site, where I learned the fundamentals of good manufacturing practice (GMP) and had opportunities to work on special projects in many departments. Due to this variety of experiences, I was offered a position as a process engineer for a contract manufacturer. There, I gained more experience, working with big pharma, startups, and on R&D projects. I was eventually recruited to work with Sartorius Stedim Biotech. I believe it was due not only to my varied experience but also because I enjoy working with people, can manage change well, and am an active member of ISPE.
PECK: I graduated with a degree in chemical engineering and a minor in biomanufacturing. I was hired as a general production support engineer overseeing issues across the entire plant, and later offered the opportunity to be the fermentation process engineer so that I could focus my skill set.
What do you think the future will bring?
BERNAL: The future looks very diverse. A myriad of start-ups with aggressive timelines are popping up all over the country and they’re developing the new generation of genetic therapies and antibodies. This translates into a highly competitive and innovative environment that will benefit patients worldwide.
HYDOCK: Increased scrutiny over autologous medicine and high scrutiny for pricing. One autologous treatment can cost a million dollars. The challenge will be reconciling high-priced technologies with the overarching need for personalized medicine.
PECK: At many manufacturing facilities, there are still a lot of unnecessarily manual operations. I suspect that the future will bring complete automation to fermentation.
What advice would you give to individuals interested in your area?
BERNAL: Stay awake! This industry is evolving permanently and you need to stay up to date. There is a shortage of highly qualified individuals overall, but the turnaround rate is also high as people move between companies quite frequently. Most importantly, everyone knows everyone, so it is critical not to burn any bridges.
HYDOCK: Build your network and your experience by joining professional organizations such as ISPE. Any experience that you can get in other roles such as quality control, manufacturing, validation, and process development will help lay a strong foundation for being able to speak technically and proficiently.
By: John Balchunas, Chris Smith, and Lucas Vann
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About the Authors
John Balchunas is Assistant Director, Professional Development Programs, at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), where he has responsibility for program management, business development, and partnership. Balchunas previously served as the director of workforce development for the North Carolina Biotechnology Center, an internationally recognized nonprofit corporation charged with creating jobs through support of research, education, and business. In an earlier career, John worked as a technical writer in the biotechnology and medical diagnostic industries. John holds a master of science degree in technical communication and a bachelor of science degree in microbiology from North Carolina State University.
Chris Smith, an ISPE member since 2014, serves as Graduate Programs Coordinator and Instructor of two graduate-level courses at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC). He has been involved with developing BTEC’s academic programs and increasing industry ties since joining BTEC in 2011. Smith holds a master of science degree in molecular physiology and an MBA in marketing; he currently serves as the NCSU Student Chapter ISPE Faculty Advisor.
Lucas Vann manages the automation and engineering group at North Carolina State University’s Biomanufacturing Training and Education Center (BTEC). He has over 15 years of experience in upstream process development, scale-up and automation. He is founder of Biozaivan LLC, a consulting company specializing in advanced automation, process development, data analytics, and predictive maintenance and control. Vann leads the process analytical technology initiative at BTEC and is currently completing his PhD (ABD) in bioprocessing at North Carolina State University. He holds bachelor’s and master’s degrees in biosystems engineering from McGill University in Montreal, Canada.