Biopharmaceutical Manufacturing Industry Skill Standards

This document from the Northeast Biomanufacturing Center and Collaborative offers an overview of the skills and knowledge necessary for success in the biopharmaceutical job market. It is designed for community college or technical college instructors helping students preparing to work in pharmaceutical companies, biotechnology companies, and clinical laboratories. The document includes information to help construct curriculum, courses and modules, and purchase equipment for education and training for ten biomanufacturing jobs including: Process Development Associate, Validation Specialist, Manufacturing Technician Upstream, Manufacturing Technician Downstream, Instrumentation/Calibration Technician, Chemistry QC Technician, Microbiology QC Technician, Environmental Health/Safety Technician, QA Documentation Coordinator, and Facilities Technician positions. A detailed job analysis including job functions, competencies, academic and technical knowledge, and familiarity with specific equipment/tools requirements are systematically presented for each position area.