Senior Manufacturing Associate

We at Global Life Science Hub are recruiting on behalf of an innovative biotech company based in Chicago, IL, that is rapidly expanding after securing two FDA approvals and advancing a strong pipeline of assets. As the company transitions from R&D to full-scale commercial operations, they are scaling up their manufacturing capacity from 50L to 2000L by the end of the year and aim to double their workforce within the next two years.

We are seeking a Manufacturing Associate II to support their growing operations. In this role, you will assist with the downstream purification of mammalian cell cultures, focusing on processes from 50L to 1000L in a cGMP environment. You will contribute to the production of recombinant proteins for mammalian-based biosimilars, working hands-on with AKTA purification systems and tangential flow filtration (TFF), while ensuring compliance with batch records and regulatory standards.

Key Responsibilities:

• Perform downstream purification processes, including column packing and data analysis in a cGMP environment.
• Assist with the preparation and review of quality management documents, such as deviations and change controls.
• Support the execution of clinical and commercial batches.
• Collaborate with internal teams and external vendors to maintain production equipment and troubleshoot issues.
• Ensure adherence to GMP standards and environmental health and safety policies.

Qualifications:

• Bachelor’s degree in Chemical, Biological, or Biochemical Sciences, or equivalent experience.
• 3+ years of experience in biopharmaceutical manufacturing, with a focus on downstream processes.
• Experience with AKTA purification skids, TFF, and working in a cGMP environment.

This is a great opportunity to join a biotech company during a dynamic period of growth, with exciting developments and further expansion projected through 2030.