Rick Lawless
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Several years ago, after conducting yet another disappointing job interview, I realized that the only way I was going to find
competent manufacturing professionals was to steal them from the biomanufacturing plant down the street or train existing
ones. Not wanting to design my own comprehensive in-house training program, I decided to join a team that would design the
concept for a revolutionary new training center. The new center's aim was to produce graduates and trainees that know about
current good manufacturing practice (cGMP) compliance, understand the basics of unit operations, and have actually touched
a working bioreactor or utility skid.
Educators, industry professionals, and government officials worked together to secure a grant for almost $39 million to build
the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University. It took another
$7 million from state government and donations from local industry to install the initial process equipment.
The center is now the largest of its kind in the world and is consistent with the NC State University mission to produce graduates
who hit the ground running. BTEC provides hands-on education and standardized training for manufacturing biomolecules. The
curriculum was designed using data from a survey of local industry professionals conducted by the North Carolina Biotechnology
Center.1
Introductory courses teach students the fundamentals of cell growth and biomolecules. Intermediate courses help students transition
from bench-scale to industry equipment. In the advanced courses, students are exposed to cGMP, large-scale equipment issues,
and clean utilities. The scope of learning is broader than what a new employee would experience on the job, so graduates with
a minor in biomanufacturing are uniquely qualified and can tackle most first assignments with ease.
I was so convinced of the long-term value of the center and its potential to support industry growth that I went to work for
BTEC in 2006. For companies, BTEC is cost efficient and produces graduates with skills that can be easily modified to fit
company procedures. BTEC students learn to work in clean rooms, document their work, and conduct failure investigations. They
also learn how to read engineering drawings and can list the components of clean utility systems and explain the function
of each.
Most importantly, after assembling and disassembling bioprocessing equipment, troubleshooting leaky vessels and plugged valves,
and reacting to other operational failures, students come out of the class with wealth of knowledge and skills. BTEC is also
charged with keeping up with, and even creating, technology improvements and revising its curriculum accordingly. Skilled
professionals are important now, and will be even more important as Big Pharma companies try to reduce costs to reach new
markets in developing countries and compete against manufacturers of follow-on biologics.
Early BTEC successes include growing enrollment, high placement rate, and several training and development contracts. The
ultimate proof of BTEC's success will come as companies expand or build new plants in NC and when former students return to
BTEC to recruit for the new positions that have been created.
Rick Lawless is an associate director at the Golden LEAF BTEC, NC State University, Raleigh, NC, 919.513.0969, rick_lawless@ncsu.edu
REFERENCES
1. North Carolina Biotechnology Center; North Carolina Biomanufacturing and Pharmaceutical Training Consortium. The model
employee: preparation for careers in the biopharmaceutical industry, Raleigh, NC;2005 May.
