Downstream Manufacturing Scientist
Kashiv Biosciences LLCNew Jersey, United States
Posted June 3, 2025
Full Time
About the Company
Kashiv Biosciences LLC specializes in biosimilar manufacturing and process equipment support, offering HVAC and BMS maintenance, equipment validation, and intellectual property services for downstream cell culture processes. The company operates in a GMP-compliant environment, providing technical expertise in bioreactor, fermenter, and downstream process equipment maintenance and IP strategy development.
Job Description
Downstream Manufacturing Scientist will execute purification of mammalian cell-based cultures and produce recombinant proteins. This hands-on position requires expertise in AKTA purification, TFF and cGMP manufacturing. The role involves batch execution, process troubleshooting, data analysis, and compliance with GMP regulations. Collaboration within a team is key.
Requirements
- Perform downstream process at multiple scales in a cGMP environment
- Uses programs to collect and evaluate operating data
- Establishes operating equipment specifications and improves manufacturing techniques
- Coordinate the conduction of investigations and corrections
- Works with other teams and outside vendors
- Ensure that engineering and clinical batches are executed in a timely manner
