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Preparing the workforce pipeline

Biomanufacturing is a constantly evolving industry. And with rapid development comes a need for a highly trained and prepared workforce. State leaders met virtually to discuss the biggest changes they are seeing in the industry, how they are working to prepare the worker pipeline and what they are doing to adapt to developments around the COVID-19 pandemic.

Panelists: Samuel M. Taylor, president, North Carolina Biosciences Organization (moderator) John Balchunas, workforce director, National Institute for Innovation in Manufacturing Biopharmaceuticals, assistant director, Prof. Dev. Programs, Biomanufacturing Training & Education Center, North Carolina State University Brent Harpham, executive director for BioNetwork and Life Sciences, N.C. Community College System Rick Lawless, training manager, AveXis Martin Meeson, president and CEO, FUJIFILM Diosynth Biotechnologies Hernán Navarro, director, Biomanufacturing Research Institute and Technology Enterprise, N.C. Central University Mike Renn, director, instructor, N.C. Pharmaceutical Services Network at Pitt Community College Kimberly van Noort, senior vice president for academic affairs, chief academic officer, UNC System

Due to social distancing efforts, this month’s round table took place via videoconference. The event was sponsored by BioNetwork, NCBIO, National Institute for Innovation in Manufacturing Biopharmaceuticals, Golden LEAF Biomanufacturing Training and Education Center, Pitt County Development Commission and AveXis. The tran- script was edited for brevity and clarity.

52 BUSINESS NORTH CAROLINA LIFE SCIENCES ROUND TABLE

HOW HAS THE PROCESS OF BIO- whole of the process, from the opening impacts the workforce as a whole. It MANUFACTURING CHANGED of the vial all the way through actually trickles all the way down to operators AT YOUR FACILITY OVER THE putting the drug substance in the bottle. and technicians as a different cadre LAST FIVE TO SEVEN YEARS? The other big [change] is around analyt- of person is needed to interface with ics. You know from your interactions with that data to know how to react. As a MEESON We’ve moved a lot more away the [U.S. Food and Drug Administration] result, companies are actively seeking from the traditional stainless-steel type of that one of the things they are extremely out data analytics talent to build a more operation. [Previously,] there has been a focused on is analytics, around the mol- intellectually diverse workforce.

lot of stainless steel, a lot of cleaning, ecule when you go to get it registered. SPONSORED SECTION and we’ve moved now to the more We did an analysis the other day HOW HAS YOUR WORK- disposable systems. where we looked back over about 10 FORCE ADAPTED TO NEW We are predominantly, nearly totally, years, and virtually all of the equipment MANUFACTURING TECHNIQUES? in the disposable systems for all of and some of the techniques that we’re the small-scale cell culture antibod- using today for analytics weren’t even LAWLESS We are a gene therapy ies, which in our case is 2,000L, around 10 years ago. company. Our gene therapies treat that we make across the whole of genetic diseases such as spinal muscu- the network, including this facility BALCHUNAS When I looked back 10 lar atrophy, Rett Syndrome, genetic ALS. in North Carolina. That’s been quite to 15 years ago, “single-use” was a Other companies make products for a big change, and something that’s buzzword, and now it is a reality and hemophilia and Duchenne muscular been mainly in the upstream. We’ve very much the reality everywhere. dystrophy. Genetic diseases are caused all heard of the single-use bioreactors, I think one area we are definitely by a mutation in a patient’s DNA, so that but we now have many more items in seeing significant change is around they can’t produce an important func- the downstream which are moving to the use of data analytics and automa- tional protein. single-use as well. tion, and it’s a paradigm shift in ways. So many of the gene therapies use In our facility in Texas, we are almost As companies begin leaning more vectors, sometimes virus particles, to exclusively single-use throughout the heavily on data to make decisions, it deliver good DNA to the target cells so

DNA using PCR techniques instead short courses and also held its second of techniques looking for proteins. annual two-day pharmaceutical But those skills are needed in our chemistry seminar program. quality control laboratories that may- The community college received be are not available in the general $650,000 from the grant, and $400,000 industry at the existing companies. from Pitt County Economic Devel- opment Commission with which A SURVEY LAST YEAR SHOWED THAT SPONSORED SECTION we established the Pharmaceutical WE’RE EXPECTED TO CREATE, AS AN Services Network at Pitt Community INDUSTRY, MORE THAN 5,000 JOBS College, a 6,000-square-foot facility BY THE END OF 2024. HOW IS OUR to teach people how to make tablets UNIVERSITY SYSTEM PREPARING and capsules. Since we went active TO COPE WITH THAT DEMAND FOR in October 2017, we have completed EMPLOYEES? about 45 classes, training more than 350 individuals, many of them from VAN NOORT Our universities are in a local industry, which was the reason constant process of scanning work- that this all came together with Mayne BRENT HARPHAM force needs and working hard to Pharma and Thermo Fisher Scientific. respond. The UNC System has recently We’ve also trained a number of public N.C. Community College completed a study of workforce needs classes through the community col- System in the STEM and health sciences areas lege. A number of those people ended and of our future capacity to meet that they can produce functional protein. those needs. We looked at enrollment Often, this requires only a single dose. projections, seat availability projections So our product is basically DNA in a vec- in key areas, capacity of critical facilities, tor, which was a little different than the and other key considerations. Across other biotech products. the system, universities are starting The thing that we look for the most up new programs in emerging fields — especially in new hires — is a good such as data science, supply chain background in biology and chemistry. management, and data curation, The processes aren’t as well-defined, among others. We are also helping to so sometimes it requires a lot of facilitate conversation between our information and investigation to figure institutions and industry to inform the out how to proceed. The other skills development of new programs and that we look for are biomanufacturing the evolution of existing programs. skills. As Martin mentioned, we are all in WHAT ARE YOUR COMPANIES OR disposables. So some background SYSTEMS DOING TO PROVIDE TRAIN- in disposables. Automation has been ING IN THEIR RESPECTIVE AREAS AND SAMUEL M. TAYLOR mentioned before. Some of the com- SPECIALTIES? panies in our industry use some old- North Carolina Biosciences school technology such as adherent RENN East Carolina University and Pitt Organization cell culture, which is different than Community College got a $1.75 million the suspension. That’s kind of a step grant, from the Golden Leaf Founda- back in technology, but it’s some- tion, to develop training facilities to up employed at Mayne Pharma and times a requirement. provide training services in support of Thermo Fisher Scientific. A lot of times, our vectors are the pharmaceutical industry. The Last summer Pitt Community Col- intracellular, so we have to get them university received $1.1 million and has lege, Pitt County Schools, Thermo out of the cells. So we require a little built on the great program they already Fisher Scientific and the N.C. Biotech- bit of a different biomanufacturing had in their chemistry department nology Center partnered to launch a background. The regulatory is a little around [good lab practices], while also pilot for the newly created program bit more important than it was be- adding additional equipment to help called the Pharma K12 Workforce De- fore, especially with new products. with training and troubleshooting within velopment Training Initiative. Together And then our QC testing would be on the industry. They’ve implemented the team identified seven graduating

54 BUSINESS NORTH CAROLINA THETHE TRADETRADE ASSOCIATION FORFOR NORTHNORTH CAROLINA’S We work with LIFE SCIENCE INDUSTRY publicWe leaders, work with research LIFE SCIENCE INDUSTRY institutionspublic and leaders, life science research companiesinstitutions to accelerate and life innovation science for improvedcompanies human health to accelerate and quality innovation of life. for improved human health and quality of life.

735 companies with 130 $55K+ for early career salary $3.1 BILLION in new 735of those companies in production with 130 and $55K+in biomanufacturing for early career salary facilities$3.1 BILLION since developmentin new ofbiomanufacturing those in production and in biomanufacturing offacilities biomanufacturing since development training biomanufacturing $83.3 BILLION in annual programsof biomanufacturing training $93K+ average salary for NC $83.3economic BILLION activity in annual programs $93K+biotech average job salary for NC economic activity 3000-5000 new biotech job 248,000 jobs biomanufacturing3000-5000 new jobs 248,000 jobs expectedbiomanufacturing in next 3-5 jobs years expected in next 3-5 years

SAM The Life Science Industry in North Carolina is driving innovation SAMTAYLOR Theto improve Life Science our health, Industry strengthen in North ourCarolina agriculture is driving industry innovation and TAYLORNCBIO toprovide improve good our paying health, jobs strengthen for employees. our agriculture The industry industry is investing and President NCBIO providein communities good paying and supportingjobs for employees. education The and industry training isto investing equip President inincumbent communities workers and andsupporting students education for the jobs and of training the future. to equip incumbent workers and students for the jobs of the future.

www.ncbioscience.net @ncbio company/ncbio www.ncbioscience.net @ncbio company/ncbio

2020-ncbio_business-nc-full-bleeds.indd 1 4/3/20 2:52 PM

2020-ncbio_business-nc-full-bleeds.indd 1 4/3/20 2:52 PM LIFE SCIENCES ROUND TABLE

WHAT ARE THE COMMUNITY COLLEG- and biopharmaceutical technology. And ES DOING TO ADDRESS THE GROW- there are also additional community col- ING NEED FOR SKILLED WORKERS IN leges bringing these types of programs, BIOMANUFACTURING? which is providing not only a skilled workforce but the ability for these HARPHAM From the BioNetwork individuals to transition into the higher side, we work closely with commu- educational programs. nity colleges and customize training SPONSORED SECTION directors across the state, to ensure WHAT IS THE GOLDEN LEAF BIOMAN- that biopharmacy industry partners UFACTURING TRAINING AND EDUCA- have customized training content that TION CENTER AT N.C .STATE DOING they need. It’s a pull system rather TO MEET THE DEMAND? than a push. We offer training on multiple disciplines including aseptic BALCHUNAS I think it’s critical to processing and quality systems, frame the nature of this demand. In validation, upstream and downstream. talking to companies, we hear encour- On the certificate side, we recently aging words that we are well poised to completed a revamp of the BioWork meet their technical training needs. By KIMBERLY VAN NOORT program. We had industry reps as well and large, I’d wager that many of the UNC System as community colleges represented biopharma-oriented education pro- during that revamp. The BioWork programs in the state are well positioned gram is a 136-hour certificate program, to deliver education and training seniors that were good students, and we have increased the number aligned with biopharma skill needs. met the established minimum test- of community colleges offering this Yet, what becomes clear is that most ing requirements, with no immediate program up to 10. These are the 10 companies are afraid there will be a plans to further their education. Upon colleges that have a concentration of shortage of talent five to seven years graduation, the students attended the biopharma companies in their service from now. As cell and gene therapy two-and-a-half day training session, areas. takes off, for example, these compa- receiving their certification, allowing Across the 58 community colleges, nies will be in a pinch for talent. And I each to be invited for interviews with there are several associate degrees think COVID-19 is only going to Thermo Fisher, [from] which two of offered. Some of them are coupled intensify that need for talent as [we them were employed. with specific certificates in the areas of see] more products coming online. This year, we’re opening it up to all biotechnology, bioprocess technology BTEC has undergraduate and gradu- seven Pitt County high schools. Unfor- ate programs that are training students tunately, given the circumstances, it’s at different levels. Our undergraduate been kind of a bumpy road getting the programs are reaching chemical engi- young people lined up. But our goal neering majors as well as microbiology is to hopefully train up to 12 students majors and life science majors. again this summer. They’ll graduate on I oversee the hands-on technical a Saturday, train the following week training for the industry and bringing in and then interview the following week incumbent workers for training. at Thermo Fisher. At about the one-year-and-a-half NAVARRO One of BRITE’s missions mark, we had follow-up meetings with is workforce development, and it the manufacturing leads with Mayne centers around a four-year pharma- Pharma and Thermo Fisher to see if ceutical sciences degree where the there was anything else we could do. students get a broad exposure to the What we heard back from them was biomanufacturing industry. And we very exciting: Their production rates have an advisory committee that has were up, their reject rates or issue members in the private sector, and rates were down and [there was] a JOHN BALCHUNAS we’re soliciting feedback from them greatly improved attitude, because to adjust our curriculum so it meets people had a little better understanding North Carolina State their needs when the students come of what they were doing. University out.

56 BUSINESS NORTH CAROLINA There has never been a more important time to support the biopharmaceutical industry.

As home to many biopharma manufacturers and thousands of their employees, North Carolina’s BioPharma Crescent is poised to help you navigate this uncertain time.

Whether you represent an existing business in our region, or are looking for a new location, please let us know how we can help.

Thank you for everything you do for the health and well-being of people in our communities and around the world.

Learn more at BioPharmaCrescent.com LIFE SCIENCES ROUND TABLE

When we work with NCBioImpact sociate degree program into the BRITE parents. But we need to educate and NCBIO, we also get great feedback Pharmaceutical Sciences program for a parents on what biotech is and that as far as what the industry is looking for. four-year degree. manufacturing in particular offers a We’ve adjusted some of our coursework We’ve had around 10 graduate stu- pretty good career. In general, not many based on that information. For example, dents in BRITE each year. Almost 100% parents out there know about biotech, we started to add disposable tubing in of them go into the industry after they and they have a negative feeling about our bioprocessing labs now. graduate. We’re going to try to increase manufacturing: It’s dirty and oily and

SPONSORED SECTION And we’re hiring a full-time recruiter. the number of students in our graduate steamy. So not only do you educate the We had a part-time recruiter, but part- program also. middle schoolers, high schoolers but time is not as good as full-time. Her also the parents. goal is to go out to high schools and RENN One of the things that has been the junior highs and spread the word interesting to me over the last couple about how good a career in biomanu- of years is how little everybody under- facturing is. stands about the biopharma business. When I talked to the students at They seem to think that everybody that BRITE, some of them say, “I’m a scien- works in the business has a Ph.D. They tist, but I’m not so sure I want to work don’t see anything that interests them, in a lab.” but when you start talking to them about What I want the recruiter to do is let all the possible opportunities, their eyes people know that these are great jobs. brighten up. And oddly enough, I think things like COVID-19 help us, because there’s so much emphasis on the medical industry to show how important the industry is.

MEESON We all have people within our organizations who have quite transferable skills. It’s not all high degrees of chemical and biological and RICK LAWLESS DNA manipulation. There are a lot of AveXis practical and mechanical aspects to the work that we do. At [Fujifilm Diosynth Biotechnologies], we promote [the biotechnology industry] at the high ARE THERE THINGS THAT THE INDUS- school level. And I think we’ll probably TRY CAN DO TO HELP MAKE MANU- work with some of your institutions FACTURING CAREERS MORE VISIBLE directly or indirectly to make sure we TO STUDENTS? do that, because that’s a generic thing MIKE RENN across the industry that I think we all VAN NOORT The biggest thing you Pitt Community College need to follow. can do to help the N.C. system in our four-year universities is remain strong HARPHAM On the community college partners with them, to remain and stay You’ll work for great companies. You’ll side, we work to link those middle in their advisory boards, support them have tons of opportunities once you get school or high school students with in their efforts to recruit students and in there. You’ll use your science in all the community colleges and the support them in ways that enable them kinds of different ways. So get the basic STEM-related careers. We make that to do that outreach that you need. training here at BRITE, and then you’ll connection to help fuel that pipeline This can be done in lots of different be really well-prepared to move wher- for future staffing. ways, but I think that putting the power ever you want after you start working of the industry’s needs behind what at these companies. LAWLESS The other audience to reach we are doing is going to make us a We’re also working with the commu- besides the students are their parents. lot more successful. We’re coming nity colleges. We have four articulation Students will learn things while they’re into some difficult times now, and we agreements in place. It’s a lot easier for playing on their phones. They know don’t want to lose ground. We need those students to move from their as- electronics really well. The same with the support that we can get for these

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very good programs already in place. It’s VAN NOORT This is going to force us going to be critical. into rethinking a lot about how we do business. This is going to change HOW IS COVID-19 IMPACTING YOU how every single biomanufacturing TODAY, AND WHAT CAN WE EXPECT industry member out there works IN THE FUTURE AS WE RESPOND? with technology and how we educate students to meet those changes, and NAVARRO

SPONSORED SECTION We have a lot of people I believe that will be the No. 1 result taking labs, and what some of the that we’d see out of this that’s going faculty [members] are doing is trying to be a positive. to identify some videos that the students can watch, but it may be HARPHAM We continue to provide that you have to develop video top-tier training, and part of that is content in the future for these [through] virtual reality. We also are e-learning classes where students looking at enhanced implemented can have a virtual lab experience. It’s e-learning as supplemental support. not hands on, but at least they’ll be With the virtual reality training, we’ve able to have an idea of what the HERNÁN NAVARRO simulated multiple scenarios; it involves instruments look like and how they going into a facility and mapping out function, but it’s going to be a Biomanufacturing Research everything within a specific location challenge. Limited access to high- Institute and Technology where there’s a mixing chamber, or it speed internet could limit or exclude could be a fill line, for example. those in rural areas or those with Enterprise It allows the individuals to train in a limited financial resources from setting that could be hazardous or dan- e-learning opportunities. gerous or not accessible at times, given

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© 2020 The National Institute for Innovation in Manufacturing Biopharmaceuticals AMERICAN INNOVATION AT WORK these pharmaceutical companies are puzzle. I think from BTEC’s perspec- operating 24/7. So having that availabil- tive, I don’t think we’ve ever reached ity for someone to put on a headset and what I would call capacity in terms of go through motions and have issues ar- throughput. But if the industry demand rive and then go in and solve the issue is as big as it says it is, at some point is key. And we’ll continue to explore we will hit a ceiling or wall in terms those scenarios with companies across of capacity, and that wall could be the state. limitations in space or limitations in instructional expertise. whether that’s WHAT RESOURCES DO YOU NEED space, whether that’s faculty. I don’t FROM THE STATE TO PROVIDE UP- know which one it’s going to be first. I TO-DATE TRAINING TO MEET THIS think we could hit capacity at some GROWING DEMAND? point if the demand keeps growing. Several people mentioned online NAVARRO From the N.C. Central side, learning, and I think that’s going to be there are certain things that we would like one of the most fascinating things for to add to our training, but they’re very me to watch from NIIMBL’s perspec- expensive. MARTIN MEESON tive. I’m listening to educators all over For example, automation. We really the country deal with the exact same don’t have it in our budget to be able FUJIFILM Diosynth issue right now: How do you teach to set that up. It would be nice to have Biotechnologies technical hands-on labs online? I think some extra funding for that, even if it’s two years from now, there’s going a one-time or if it’s over a few years, to to be a lot of innovation in the whole build in these new programs. And we’re BALCHUNAS Funding sounds so world of online learning, and I think trying to move a lot of our courses online. generic, but it is a critical piece of the this is going to be a catalyst.

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