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Upstream/Downstream Scientist

Posted 2024-11-14

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💎 Seniority level: Entry, 1-6+ years depending on position

📍 Location: United States

🔍 Industry: Biopharmaceutical

🏢 Company: Global Life Science Hub

⏳ Experience: 1-6+ years depending on position

Requirements:
  • 1-2 years of experience in cell culture and bioreactor operations, including GMP and Aseptic Manufacturing experience for upstream roles.
  • Proficiency with single-use manufacturing consumables and prior experience in scale-up manufacturing activities.
  • At least 1-2 years of experience in Downstream Processing with expertise in TFF operations.
  • Hands-on experience in running chromatography systems and column packing, with knowledge in Unicorn software.
  • Familiarity with depth filtration processes and knowledge of cGMP regulations.
Responsibilities:
  • Execute mammalian cell culture processes to produce recombinant proteins for Biologics, managing cell culture batches up to 2000l.
  • Operate bioreactors and establish operating equipment specifications.
  • Collaborate with manufacturing associates and engineers, effectively interpreting and providing instructions.
  • Initiate batch records, protocols, and oversee investigations in a cGMP environment to ensure compliance.
  • Review and document manufacturing and packaging batch records, maintaining adherence to safety standards and GMP guidelines.
  • Perform purification processes for mammalian cell cultures, including handling purification volumes up to 2000l.
  • Operate AKTA purification skids and TFF operations, contributing to column packing and process troubleshooting.
  • Direct technical aspects of purification and collaborate with external vendors on equipment maintenance.
  • Ensure compliance with BLA requirements for clinical and engineering batches, following GMP policies and safety protocols.
  • Manage batch execution, ensuring efficient issue resolution and process improvements.
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