Manufacturing Operations Specialist

3 days ago


Chicago, Illinois, United States Global Life Science Hub Full time
Senior Manufacturing Associate

We are seeking an experienced Manufacturing Associate III to join our Global Life Science Hub in Chicago, IL. This individual will play a critical role in the production of mammalian-based biosimilars, focusing on purification processes ranging from 50L to 1000L in a cGMP environment.

About the Role

This position involves hands-on work with AKTA purification systems and tangential flow filtration (TFF) while overseeing batch records and ensuring compliance with regulatory standards.

Key Responsibilities:
  • Execute downstream processes in a cGMP environment, including troubleshooting and data analysis.
  • Support the purification of mammalian cell cultures and recombinant protein production.
  • Review and prepare quality management documents, such as deviations and change controls.
  • Ensure timely execution of clinical and commercial batches.
  • Collaborate with teams and vendors to maintain production equipment and resolve technical issues.
  • Lead compliance with GMP and environmental health and safety policies.

The ideal candidate will have a Bachelor's or Master's degree in Chemical, Biological, or Biochemical Sciences, along with 5+ years of experience in biopharmaceutical manufacturing with a focus on downstream processes.

Salary:

$120,000 - $150,000 per year.


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