Manufacturing Associate, Downstream

Manufacturing Associate, Downstream (Night shift)

Location:

Tustin, CA About the Role

We are partnering with a leading biologics CDMO seeking a Manufacturing Associate, Downstream to support GMP biopharmaceutical manufacturing operations. This role is responsible for executing downstream processing activities including chromatography, filtration, purification, aseptic manufacturing, and documentation. You'll play a key role in ensuring the safe, compliant, and timely production of high-quality biologic therapies within a regulated manufacturing environment.

• Perform downstream manufacturing operations in accordance with cGMP guidelines and standard operating procedures.
• Operate, maintain, and troubleshoot chromatography skids, filtration systems, and other production equipment.
• Execute protein purification processes including affinity, ion exchange, size exclusion, hydrophobic interaction chromatography, and tangential flow filtration (TFF).
• Support aseptic processing, product filling, media fills, and cleanroom operations.
• Prepare media, buffers, and materials required for manufacturing activities.
• Complete batch records, GMP documentation, SOP revisions, and production reports.
• Maintain equipment, monitor inventory levels, and ensure production readiness for manufacturing campaigns.
• Contribute to continuous improvement initiatives and support assigned manufacturing projects.

• Experience working in a GMP-regulated environment.
• Knowledge of downstream bioprocessing, purification, filtration, and aseptic manufacturing techniques.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.