The Graduate Certificate Program will be for students who want a one or two year coordinated series of graduate level courses but do not wish to complete a Master's level degree. The Graduate Certificate will complement the Post Baccalaureate Certificate which is based only on undergraduate courses. The GCP requires advanced "hands-on" intensive laboratory courses in both upstream biofermentation and downstream bioseparation and therefore our certificate graduates will have training in all aspects of biopharmaceutical processing.
Eventually, this GCP could lead to development of nationally and internationally recognized certification such as "Certified Biomanufacturing Professional" in collaboration with a professional society such as SME, SBE or ISPE. The identification of this GCP on student’s transcripts will be very beneficial for those who wish to advance in their work environment in North Carolina biomanufacturing, biopharmaceutical or biotechnology companies. Particularly valuable for the students is their advanced training in FDA current Good Manufacturing Practice (cGMP) and other FDA regulatory guidelines and advanced regulatory affairs and bioanalyatical courses.
COE students, non-COE students and particularly non-degree graduate students from local biotechnology companies will be able to enter this GCP by taking courses in Microbiology (BEC/MB 520) or basic Molecular Biology (BIT 510) creating a common entry. To complete the GCP, students will take a series of five required 8-week "hands-on" laboratory courses + I elective regulatory compliance, gene expression or bioanalytical course. These courses include advanced bench-scale upstream fermentation (BEC/MB 520) or BIT Fermentation of Recombinant Microorganisms (BIT/CHE 563) classes and an advanced bioseparation course. Included also will be two required courses in intermediate (BBS 526) and large scale cGMP Fermentation (BEC 580) or Bioseparation Process Development (BEC 536) and Large scale cGMP Downstream Protein Recovery (BEC 585).