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. Key Responsibilities 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. Qualifications & Requirements 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. #J-18808-Ljbffr BioTalent