We at Global Life Science Hub are recruiting on behalf of an innovative biotech company based in Chicago, IL, that is experiencing rapid growth after securing two FDA approvals and developing a robust pipeline of assets. As the company transitions from R&D to full-scale commercial operations, they are scaling their manufacturing capabilities significantly, aiming to grow from 50L to 2000L by year’s end and doubling their workforce within two years.

We are seeking a Manufacturing Associate III to join their team during this exciting phase of expansion. This position will be instrumental in the production of mammalian-based biosimilars, focusing on purification processes ranging from 50L to 1000L in a cGMP environment. You will play a hands-on role in managing AKTA purification systems and tangential flow filtration (TFF) while overseeing batch records and 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.

Qualifications:

• Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences.
• 5+ years of experience in biopharmaceutical manufacturing with a focus on downstream processes.
• Proficiency with AKTA purification skids, TFF, and cGMP documentation.

This role offers the chance to contribute to a company at the forefront of biotechnology, with opportunities for growth as they continue to expand through 2030.