Manufacturing Associate, Downstream

BioTalent; Tustin (CA); On-site; USD 60,000 - 85,000; Full time

Job summary

BioTalent in California is seeking a Manufacturing Associate, Downstream (Night shift) to support GMP biopharmaceutical manufacturing. You will perform chromatography, filtration, purification, aseptic processing, and related documentation in a regulated environment.

The role emphasizes hands-on downstream processing, equipment operation, batch records, and collaboration with the manufacturing team to ensure quality and timely production of biologics.

Qualifications

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

Responsibilities

• Perform downstream manufacturing operations in accordance with cGMP guidelines and SOPs.
• Operate, maintain, and troubleshoot chromatography skids, filtration systems, and other production equipment.
• Execute protein purification processes including affinity, ion exchange, size exclusion, and tangential flow filtration.
• 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 campaigns.
• Contribute to continuous improvement initiatives and support assigned manufacturing projects.

Skills

GMP compliance

Downstream bioprocessing

Purification techniques

Filtration systems

Aseptic manufacturing

Job description

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.