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Position Summary
- The Downstream Manufacturing Manager is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars.
- The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment.
This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.
- Work in a team environment to execute batches and can work independently with minimum supervision.
- This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
Essential Duties & Responsibilities
- Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
- Provides technical direction in the execution and development of the purification process.
- Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
- Prepare / review all quality management related documents (Deviation / Change control / investigation reports etc.)
- Ensure that engineering and clinical batches
21 hours ago
