Biomanufacturing is the application of fundamental biotechnology and engineering principles to produce human medicines, enzymes, food ingredients, fuels and novel biomaterials. Successful production requires that future industry leaders are trained in product safety, ethics, FDA regulatory compliance, project management and sound business decisions. This SMP in Biomanufacturing (SMPB) will recruit talented US students into the first cross-disciplinary Master's of Biomanufacturing degree integrating graduate "hands-on" technical, scientific, research, and business skills. Students will be trained in 24 months in a curriculum that includes 8-week advanced laboratory courses in FDA compliant current Good Manufacturing Practice (cGMP) biomanufacturing methods, finance, accounting, project management, an industry-focused research project, professional skills training, and an industrial intern experience. The cGMP laboratory courses will be taught in the new 82,500 sq. ft. $50 million Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University (NCSU). BTEC is the largest academic biomanufacturing training facility in the US. It includes process-scale simulated cGMP teaching facilities for upstream fermentation, downstream recovery, protein purification, analytical techniques, and aseptic processing. Faculty from three colleges will teach SMPB students: Engineering, Agriculture and Life Sciences, and Management. The multidisciplinary SMPB graduate curriculum is already approved for training in small-scale (30 liter) and large-scale (300 liter) operations using BTEC state-of-the-art industrial biomanufacturing equipment. The curriculum also includes global biopharmaceutical regulatory compliance courses combined with bioscience-focused MBA courses taught by the NCSU Jenkins Graduate School of Management.
This program is preparing a more intellectually, gender, and culturally diverse workforce for the U.S. biomanufacturing industry through the coordinated education of future leaders in this industry in the physical sciences, engineering, business, and management. This workforce will facilitate U.S.-based industry to compete effectively in a fast-changing economic environment. This program will serve as a national model for other universities engaged in efforts to bolster local industry.
Normal 0 false false false EN-US JA X-NONE North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), which administered this SMP grant, is a state-of-the-art 82,000 gross square foot stand-alone facility created to educate and train the workforce for North Carolina’s biomanufacturing industry. BTEC, built in 2007 with State of North Carolina, Golden LEAF and local industry support, is the only facility of its kind in the US with industry-scale equipment in a simulated cGMP environment entirely dedicated to education and training. BTEC has an active industrial advisory board that provides feedback on the SMP curriculum, student internships and hires SMP graduates. Biomanufacturing graduate students are designated as "BIOM" Professional Science Masters students at NC State. Both Masters of (MR, non-thesis) and Master of Science (MS, thesis) SMP graduate programs have been created as a result of this grant. In additon, this grant created a Graduate Minor in Biomanufacturing and two Graduate Certificates: Upstream Biomanufacturing; Downstream Biomanufacturing. These attract students from many graduate programs to train at the BTEC facility. The BIOM SMP curricululm trains students in a cGMP environment by industry-experienced faculty using an industry-directed curriculum on state-of-the-art industrial equipment. It allows graduates to enter the biomanufacturing workforce or continue on to more advanced training with an in-depth understanding of the fundamentals of engineering, scientific, technical, workflow and FDA regulatory compliance. The BIOM SMP is the first industry-scale, cross-disciplinary, engineering –based biomanufacturing graduate program in the United States. New students are admitted in August and in January. With the enrollment of 16 additional students in the fall of year four (2013), the BIOM program at 26 students is ahead of the proposed grant schedule. All of the SMP BIOM students enrolled since 2010 are working full-time or part-time in local industry or are in advance academic positions. BTEC also attracted international BIOM students starting in 2013. To encourage working professionals to take the BIOM SMP degree programs, most of the curriculum, including many of the advanced laboratory courses are taught during the evenings at BTEC. First year BIOM SMP students complete a hands-on upstream or downstream biomanufacturing track of advanced laboratory + lecture courses. These courses are taught by industry-experienced non-tenure track and tenure track NC State faculty as well as local industry Subject Matter Experts (SMEs). They also complete courses in FDA regulatory compliance, biocatalysis and enzyme/cellular engineering, and professional skills development. At the end of year 1, each student enters a 3 month industry internship and begins their thesis research at BTEC. The industry internship between years 1 and 2 is facilitated by the Industry Advisory Board; many of the IAB companies interview the first and second year SMP PSM students during the annual BTEC/ISPE Career Fair each spring for interns and full-time positions. SMP students have interned at Novozymes North America (Franklinton, NC), Novartis (Holly Springs, NC), Novo Nordisk (Clayton, NC), Biogen-Idec (RTP, NC), Fujifilm Diosynth (RTP, NC), Catalent (RTP, NC), Advanced Liquid Logic (Morrisville, NC), PharmaSys (Cary, NC), Kymanox (RTP, NC), Bio Matrix (Greensboro, NC), NNE PharmaPlan (Morrisville, NC), Hospira (Clayton, NC), Arbovax (Raleigh, NC), Cognosci (RTP, NC), Eisai (RTP, NC), Shire Pharmaceuticals (San Diego, CA), Genentech (South San Francisco, CA), and St. Jude Children’s Research Hospital GMP Facility (Memphis, TN). These internships are in areas directly related to biomanufacturing. Often, the first year BIOM SMP student continue working in industry after completiong thier internship (during their second year) to gain additonal experience. Second year BIOM SMP students focus on advanced laboratory courses in analytical characterization techniques, a second industry practica course, statistics, and MBA courses including project management, current issues in bioscience management and legal and marketing dynamics in pharmaceutical and biotechnology. As part of the Professional Science Master’s mandate, first and second year students also complete "soft-skills" training courses on resume writing, networking, interviewing, change leadership, emotional intelligence, communication, and presentation skills. Normal 0 false false false EN-US JA X-NONE As part of their professional skills training, BIOM SMP students invite industry professionals to lecture on various aspects of biopharmaceutical manufacturing. These individuals came from Novozymes, Kelly Scientific Resources, Dendreon, TAP Biosystems, and Biogen Idec. SMP graduate students had the opportunity to spend significant time with the speakers following the seminar to gain insite on how these prefessionals developed thier careers. The firThe first cohort of BIOM SMP students graduated in May and December of 2012 were all offered industry positions prior to their graduation at Biogen Idec, Fujifilm Diosynth, Integrated Project Services, Eisai, and Hospira. These gradutes had average annual salary offers of ~$71,000. The second cohort of SMP graduate students graduated in May, 2013. Five of the six graduating students had secured industry positions prior to graduation. All students had accepted offers within 60 days of graduation at Biogen Idec, Novartis, Novo Nordisk, Hospira, and Tate & Lyle.
