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Downstream Manufacturing Associate III
2 months ago
We are seeking a highly skilled and experienced Bioprocessing Specialist to join our team at Global Life Science Hub. As a key member of our downstream manufacturing team, you will be responsible for the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars.
Key Responsibilities- Execute downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
- Operate and maintain downstream equipment, including AKTA skids and TFF systems.
- Perform in-process testing and data collection to ensure product quality and process consistency.
- Assist in preparing and reviewing quality management documents, including deviation reports, change control, and investigation reports.
- Collaborate with cross-functional teams to ensure the successful execution of engineering and clinical batches.
- Support process optimization efforts and implement improvements to enhance efficiency and product yield.
- Ensure compliance with GMP and safety regulations, including maintaining a clean and safe work environment.
- Assist in troubleshooting process-related issues and performing corrective actions as needed.
- Participate in investigations and corrective actions for deviations or process failures.
- Bachelor's degree in chemical, biological, or biochemical sciences.
- 3-5 years of related experience in downstream processing within the biopharmaceutical industry.
- Experience working in a GMP-compliant environment.
- Hands-on experience with AKTA purification systems and TFF.
- Familiarity with batch manufacturing and purification processes for recombinant proteins.
- Strong attention to detail and ability to follow protocols accurately.
- Effective communication and documentation skills.
- Ability to work collaboratively within a team and adapt to a fast-paced environment.
- Proficiency in basic computer applications, including Word and Excel.
