Lead, Cell Therapy Analytical Methods & Validation

Immix Biopharma (Nasdaq: IMMX); Los Angeles (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Immix Biopharma, Inc. in Los Angeles seeks an Analytical Method Validation Lead (Associate Director) to oversee analytical assay validation for a commercial BLA of CAR-T cell therapies.

The role leads method development, qualification and transfer of cell-based assays (potency by flow cytometry, co-culture and plate-based immunoassays) and ensures sterility and mycoplasma testing in a QC/GMP environment for FDA submissions. Collaboration across CMC to support filings.

Qualifications

• Multi-year experience with analytical method development, validation and transfer in cell therapy QC/GMP environments.
• Experience leading QbD, DOE, ICH-guided validation and development of cell-based potency assays.

Responsibilities

• Lead method development, qualification and transfer of cell-based analytical methods (potency by flow cytometry, co-culture and plate-based immunoassays) and release criteria in QC/GMP for FDA BLA.
• Support CMC activities and regulatory filings, including drafting responses for health authorities.
• Develop QC-appropriate cell/viral vector controls and establish reagent qualification programs.
• Implement analytical control strategies and risk-based approaches to CQAs/MQAs.

Job description

Immix Biopharma, Inc. in Los Angeles seeks an Analytical Method Validation Lead (Associate Director) to oversee analytical assay validation for a commercial BLA of CAR-T cell therapies.

The role leads method development, qualification and transfer of cell-based assays (potency by flow cytometry, co-culture and plate-based immunoassays) and ensures sterility and mycoplasma testing in a QC/GMP environment for FDA submissions. Collaboration across CMC to support filings.