Providing a full spectrum of training for
biomanufacturing and pharmaceutical production
These individuals perform chemical, microbiological, in-vitro or in-vivo biological assays, and routine analyses of raw materials, in-process intermediates, finished products, stability samples, environmental monitoring samples, process and cleaning validation samples, and packaging materials in support of product manufacture and clinical trial production in compliance with standard operating procedures, written test procedures, safety, FDA, cGMP, and other regulatory requirements. Depending on the company, job applicants need either an AAS in a lab/biotech discipline or a BS in biochem/chemistry/microbiology.
Example short courses offered at the NC State BTEC facility include: Microbial Contamination Control in Bioprocessing Operations.
Example courses at BRITE at NC Central University include: BRITE Seminar I - Overview of the Drug Industry; BRITE Seminar II - FDA Regulations; BRITE Seminar III - Quality Assurance; BRITE Seminar IV - Introduction to GMP; BRITE Seminar V - Intellectual Properties & Patent Law; BRITE Seminar VI - Team Work Environment -Biochemistry I Lecture & Lab; Biochemistry II Lecture & Lab; Bioanalytical Chemistry; Bioprocessing & Cell Culture Lecture & Lab; and Assay Design.
Example NC Community College BioNetwork Courses include: GMP Basics - Orientation Refresher, Deliberate Documentation QC Lab, Operations and Conducting Investigations, HPLC Basics and Troubleshooting, GC Fundamentals, Empower software training, Various hands on training on analytical equipment, Pipetting Techniques, Raw Materials, Technical Report Writing, and Writing Effective SOPs.
Find the NC Community College System BioNetwork program in your community, then click on the web site of that school and check under courses, academic programs or course catalogue to find the course of interest to you. You may also check out short courses being offered at the Capstone Center, the Validation Academy or other institutions.