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Manufacturing and Production

Processes for the manufacture of bioscience products.

Critical Work Functions

  • Understand upstream and downstream processes and the life cycle of a product
    • Perform and monitor the process to make the product or provide the service
      • Monitor gauges and recording instruments to ensure that specified conditions are maintained
        • Participate in the installation, modification, and upgrade of equipment
          • Communicate with co-workers and/or customers to ensure production or service requirements
            • Coordinate inventory
              • Maintain the production equipment and control systems
                • Keep records on process and product
                  Technical Content Areas

                  • Procedures
                    • Standard Operating Procedures (SOP) and Batch Records
                    • Good Manufacturing Practices (GMP)
                    • Aseptic Procedures
                  • Production Process
                    • Obtaining, weighing, measuring, and checking raw materials
                    • Setting up equipment for the production process
                    • Cleaning (manual and Clean in Place (CIP)) and sterilization (autoclave and Sterilize in Place (SIP))
                    • Preparing buffers and solutions
                    • Inspecting materials at all stages of process to determine quality or condition
                    • Operating reactors and recovering products
                    • Purification techniques
                    • Formulating, filling, and Inspecting product
                    • Labeling, packaging, and distributing final product