Downstream Manufacturing Specialist

22 hours ago


Princeton, New Jersey, United States Global Life Science Hub Full time
Job Overview

Global Life Science Hub is partnering with a leading biopharmaceutical company to fill a critical role in their downstream manufacturing process. As a Downstream Manufacturing Associate, you will play a key part in purifying clinical and commercial batches in a cGMP environment.

Key Responsibilities
  • Execute 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.
  • Utilize data analysis software to collect and evaluate operating data, making on-line adjustments to products, instruments, or equipment as needed.
  • Ensure timely execution of engineering and clinical batches.
  • Establish operating equipment specifications and improve manufacturing techniques.
  • Collaborate with other teams and outside vendors to resolve technical issues and maintain production equipment.
  • Adhere to GMP instructions in the manufacturing area and take the lead in following environmental health and safety policies.
  • Coordinate investigations and corrections for issues found during batch execution.
Requirements
  • Bachelor's or Master's degree in a life science field.
  • Minimum 3 years of experience in downstream processing.
  • Previous experience in an Aseptic Manufacturing environment.
  • Experience running Chromatography systems and packing columns.
  • Ability to run TFF operations.
  • Experience working with AKTA process skids and knowledge of Unicorn software is highly desirable.
  • Familiarity with GMP documentation and ability to execute engineering and clinical batches.


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