Biopharmaceutical Production Specialist
5 days ago
The successful candidate will assist with the downstream purification of mammalian cell cultures, focusing on processes from 50L to 1000L in a cGMP environment. They will work closely with internal teams and external vendors to maintain production equipment, troubleshoot issues, and ensure adherence to GMP standards and environmental health and safety policies.
Key Responsibilities:
- Perform downstream purification processes, including column packing and data analysis in a cGMP environment.
- Assist with the preparation and review of quality management documents, such as deviations and change controls.
- Support the execution of clinical and commercial batches.
- Collaborate with internal teams and external vendors to maintain production equipment and troubleshoot issues.
- Ensure adherence to GMP standards and environmental health and safety policies.
Qualifications:
- Bachelor's degree in Chemical, Biological, or Biochemical Sciences, or equivalent experience.
- 3+ years of experience in biopharmaceutical manufacturing, with a focus on downstream processes.
- Experience with AKTA purification skids, TFF, and working in a cGMP environment.
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