Manufacturing Process Specialist
7 days ago
The Downstream Manufacturing Supervisor is a hands-on role within the biopharmaceutical industry responsible for overseeing the purification of mammalian cell-based cultures and production of recombinant proteins.
This position involves technical expertise in AKTA purification skids or similar, TFF, and knowledge of initiating batch records, protocols, investigations, and other technical documents.
Responsibilities- Perform and supervise downstream processes at multiple scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
- Provide technical direction in the execution and development of the purification process.
- Evaluate operating data to conduct online adjustments to products, instruments, or equipment using various programs.
- Prepare and review quality management-related documents (deviation/change control/investigation reports).
- Ensure timely execution of engineering and clinical batches.
- Establish operating equipment specifications and improve manufacturing techniques.
- Collaborate with other teams and vendors to resolve technical issues and maintain production equipment.
- Follow GMP instructions in the manufacturing area and lead by example in environmental health and safety policies.
- Coordinate investigation and correction processes for issues found during batch execution.
- Bachelor's or Master's degree in chemical, biological, or biochemical sciences.
- A minimum of 7-10 years of related experience in the biopharmaceutical industry.
- Previous experience working in GMP and aseptic manufacturing environments.
- Familiarity with AKTA Process skids or similar and single-use manufacturing consumables.
- Knowledge of executing engineering and clinical batches, as well as GMP documentation.
$120,000-$150,000 per annum, depending on location and experience.
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