Toward the western end of the Texas A&M campus in College Station, a modern building with clean lines—and clean rooms—houses the National Center for Therapeutics Manufacturing (NCTM). In 2008, NCTM received funding from the U.S. Health and Human Services’ Biomedical Advanced Research and Development Authority to build a vaccine-manufacturing workforce. Now, leaders at NCTM see even more ways to change the industry.
The biopharmaceutical manufacturing industry’s rapid growth and expansion demands a steady stream of skilled workers. Because most engineering and science degree programs do not provide practical training in bioprocessing, management in this field lament that it takes nearly a year for a new hire to advance past internal mentorship and operate autonomously. And that’s where organizations like the National Center for Therapeutics Manufacturing (NCTM) come in. Through hands-on, technical training covering everything from bioreactors to tangential flow filtration, aseptic technique to proper documentation, and all that comes in between, we can cut the need for on-the-job training in half.
Likewise, the National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL) is committed to addressing the industry’s extreme workforce gap and has created a variety of funding opportunities to which training entities can apply. One such NIIMBL-sponsored project is “Reducing Door-to-Floor: Improving Readiness of New Hires through cGMP Hands-on Biopharmaceutical Training”, which is a hands-on training program provided by the NCTM with the specific objective of significantly reducing the time from a new hire’s first day (door) to when they can operate independently (floor).
“Door-to-Floor” immerses trainees in a rigorous digital and hands-on training program, comprised of more than one hundred hours of cGMP- and regulatory-based curricula, including aseptic microbial and mammalian cell processing using fixed and single-use fermentation and purification systems, regulatory compliance, quality management systems, and proper documentation and laboratory practices. Training participants complete five asynchronous online courses, and then participate in two full weeks of hands-on training at the NCTM in College Station, Texas.
Already, thirty-four individuals have completed the program, ranging in educational backgrounds from undergraduate students to PhD’s in chemical and biomedical engineering and science, biochemistry, medicine (human and vet), as well as biotech industry professionals from a variety of companies. Joseph Modarelli, who recently received his PhD in Genetics, shares that this training “directly impacted my recent job search as it provided the experience I needed to make the transition to a career in the pharmaceutical industry.”
Natalie Robinson, a biomedical engineering undergraduate, says Door-to-Floor “… helped me get a job at Bristol-Myers Squibb (Massachusetts) as an associate scientist/engineer” and that the skills she learned “especially helped during the interview process.” And chemical engineering junior, Carolina Serano Martinez, received a summer internship at Merck (Virginia) and subsequently was offered a co-op during the fall with them.
While students benefited greatly from this training, industry professionals also experienced rewards from their participation. Kieffer Gaskill, a manufacturing process engineer from Akron Biotechnology (Florida), stated that he has “…been able to use [learned] concepts to help further our process development…introduced (concepts) to my coworkers to better explain many of the processes we’ve been performing for years, allowing our team to further understand conceptually as opposed to just running equipment.”
BOCA RATON, Fla. – Akron Biotechnology has partnered with the National Institute for Innovation in
Manufacturing Biopharmaceuticals (NIIMBL) and the Texas A&M Engineering Experiment Station
(TEES) to pursue an exciting workforce development initiative.
2-Week Training Cohort: December 16-20, 2019 and January 6-10, 2020
The Advanced Certificate in Biopharmaceutical Manufacturing immerses participants in a rigorous
digital and hands‐on training program, comprised of more than 100 hours of cGMP‐ and regulatory‐
based curricula. Subject matter includes aseptic microbial and mammalian cell processing using fixed
and single‐use fermentation and purification systems, regulatory compliance, quality assurance and
control, process and environmental monitoring, and proper documentation and laboratory practices.
Students will complete 5 self‐paced online courses, then participate in 2 weeks of hands‐on training at
NCTM. Participants will receive 10.0 continuing education units and a certificate of completion.
The National Center for Therapeutics Manufacturing’s (NCTM) BioFORCE Summer Academy has just completed its 7th year, having served a grand total of 566 rising Texas high school sophomores, juniors and seniors, several dozen of whom have gone on to become Aggies. But the 2018 camps were made even more special by having two BioFORCE graduates engage with this year’s participants in memorable ways.