Biomanufacturing Technician Apprenticeship

Biomanufacturing Technician Apprenticeship

Issued by Northeastern University

Recipients of the Biomanufacturing Technician Apprentice badge explored the biomanufacturing workflow in the laboratory and understood the importance of safety, quality, and cGMP. They demonstrated hands-on proficiency in pipetting, using pH meter and balance, proper gowning, and clean room behavior. They were introduced to cell culture procedures and learned aseptic technique through the thaw, monitor, subculture and freeze of human fibroblasts and CHO cells. This is a level 1 badge.

Skills

Earning Criteria

  • Described the principles of good manufacturing practice (cGMP), the responsibilities and duties of the Quality Unit, and why cGMP is important in the manufacturing of biopharmaceuticals.
  • Explained the importance of controlled documents (SOPs, batch records, equipment logs, etc.) as they relate to biomanufacturing and personnel responsibilities: training, compliance, deviations, CAPA procedure, and GDP.
  • Demonstrated proper clean room protocol behavior, including gowning procedure, environmental control, particle counting, clean room classification, HEPA filtration, pressure differentials, and airlocks.
  • Demonstrated proper aseptic technique while working in a biosafety cabinet, including understanding of laminar flow, surface decontamination, organization of working place, and sterile handling.
  • Described the biomanufacturing workflow, including Upstream procedures from thaw to harvest, understanding differences between stainless steel and single-use bioreactors, Downstream procedures (types of chromatography, filtration, viral clearance), and formulation/fill finish of drug product.