Manage tech transfer and daily operations of mammalian or microbial bioreactor systems. Optimize cell culture, fermentation, and purification (chromatography/filtration). Ensure compliance with cGMP and FDA regulations, author SOPs, and investigate deviations using CAPA processes.
- The Team You Will Join: The Upstream/Downstream Biomanufacturing unit safely scales molecular and cellular therapies from benchtop lab concepts to commercial-scale manufacturing.
- The Opportunity: Seeking a Bioprocess Engineer to oversee the tech-transfer and daily operational output of mammalian or microbial bioreactor systems.
- Key Responsibilities:
- Optimize cell culture, fermentation, and purification (chromatography/filtration) parameters.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP) and FDA regulations.
- Author standard operating procedures (SOPs) and investigate deviations (CAPA).
- Required Qualifications: Bachelor’s or Master’s in Chemical Engineering, Biotechnology, or Bioengineering; 3+ years of experience within a regulated cGMP manufacturing environment.
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