Manufacturing Associate - Biologics

We are seeking a Manufacturing Associate - Cell Therapy to support clinical-stage cell therapy manufacturing operations. This role is responsible for the production of cell-based therapies (including CAR-T/TCR-T/allogeneic products) in a GMP-regulated environment. The ideal candidate will have hands-on experience in cell therapy manufacturing and strong knowledge of cGMP practices.

Key Responsibilities:

• Execute manufacturing activities in cleanroom environments following cGMP guidelines
• Operate and maintain cell therapy processing equipment (e.g., cell counters, separators, welders, sealers)
• Perform aseptic processing and support ISO 5 operations
• Assist with technology transfer, process scale-up, and manufacturing readiness
• Support deviation investigations and ensure proper documentation practices
• Prepare and maintain SOPs, batch records, and manufacturing documentation
• Ensure availability of materials, equipment, and cleanroom readiness for production
• Collaborate with cross-functional teams including MSAT and Process Development

Required Qualifications:

• Must have hands-on cell therapy manufacturing experience (CAR-T/TCR-T preferred)
• Strong understanding of cGMP regulations and aseptic processing
• Minimum 3–5 years of relevant GMP manufacturing experience
• Experience working in cleanroom environments (ISO 5/7/8)
• Familiarity with cell therapy equipment such as Nucleocounter, Sepax, Sefia, or similar
• Ability to support deviation handling and GMP documentation