Manufacturing - Process Performance

What you will get…

• > 12 years of experience in biopharmaceutical manufacturing/Inprocess control (mABs and other proteins)
• Extensive knowledge of IPC testing (upstream, downstream, formulation and sterile manufacturing)
• Experience in setting up Control strategies (including microbiological) throughout the manufacturing process
• Process and Quality data trending/monitoring (Statistical Process Control) 
• Trouble shooting in USM, DSM and aseptic/sterile manufacturing 
• Support of process validation and hold time validation
• Support in preparation of regulatory filing documents throughout the product life cycles