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Biopharmaceutical Downstream Processing Specialist
2 months ago
Global Life Science Hub is partnering with a leading biopharmaceutical company to fill a critical role in their commercial organization. The company has achieved significant milestones, including 2 FDA approvals, and is poised for substantial growth.
Job SummaryWe are seeking a highly skilled Downstream Processing Scientist to join our team. This individual will be responsible for the purification of large-scale batches in a cGMP environment, utilizing expertise in AKTA purification skids and TFF processes.
Key Responsibilities- Perform downstream processing 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.
- Collect and evaluate operating data to conduct on-line adjustments to products, instruments, or equipment.
- 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 and environmental health and safety policies.
- Coordinate investigations and corrections for issues found during batch execution.
- Bachelor's or Master's degree in chemical, biological, or biochemical sciences.
- Minimum 4-5 years of experience in the biopharmaceutical industry, with a focus on GMP and aseptic manufacturing.
- Experience working with AKTA Process skids or similar and familiarity with single-use manufacturing consumables.
- Knowledge of GMP documentation and ability to execute engineering and clinical batches.
We are a specialized Life Science headhunting firm, placing professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CRO companies. If you're interested in this role, please apply below. If this position doesn't suit you, visit our website for more vacancies.
