QC Associate

Role Summary

The QC Associate supports GMP-compliant testing of cell therapy products and in-process samples, with a focus on molecular assays, flow cytometry, and functional assays for CAR-T cells. The role includes cell culture and expansion of engineered T cells, documentation and SOP maintenance, equipment collaboration, inventory management, and contributing to QC investigations and data tracking to ensure product quality and compliance.

Responsibilities

• Execute GMP-compliant testing of cell therapy products and in-process samples, focusing on molecular assays (ddPCR, qPCR), flow cytometry, and CAR-T functional assays.
• Perform cell culture and expansion of engineered T cells, maintaining aseptic technique and quality standards.
• Contribute to drafting and updating SOPs, forms, and logbooks governing lab operations, equipment maintenance, and assay procedures.
• Coordinate preventive maintenance, calibration, and troubleshooting of lab equipment and instruments in collaboration with internal resources and external partners.
• Manage inventory of cell culture reagents, molecular assay supplies, and lab materials.
• Support GMP investigations, including out-of-specification results, assay deviations, invalid assays, change controls, and CAPAs, with a focus on molecular and functional testing.
• Assist in tracking, trending, and reporting QC data for molecular assays, cell culture, and CAR-T functional studies.

Qualifications

• Required: BS or MS in Biological Sciences, Immunology, or a related field.
• Required: 2+ years in pharmaceutical or biotechnology industry, including cell therapy/CAR-T experience.
• Required: Hands-on experience with molecular assays and flow cytometry.
• Required: Experience in cell culture and performing CAR-T functional assays.
• Required: Familiarity with GMP-compliant lab practices and QC data tracking.
• Required: Excellent written and oral communication skills.

Skills

• Molecular assays (ddPCR, qPCR)
• Flow cytometry
• Cell culture and CAR-T functional assays
• GMP-compliant lab practices and QC data tracking
• Documentation and SOP maintenance
• Strong written and verbal communication

Education

• BS or MS in Biological Sciences, Immunology, or a related field