Manufacturing Associate Job at global life science hub in Piscataway

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.