Cell Therapy Analytical Method Validation Lead (Associate Director)

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

The Cell Therapy Analytical MethodValidation Lead (Associate Director) is responsible for analytical assay validation for commercial BLA of CAR‑T cell therapies.

Our Values

What You Will Do

• Lead method development, qualification and transfer of all cell-based analytical methods (potency - flow cytometry, co‑culture and plate‑based immunoassays) as well as sterility, mycoplasma, and all other release criteria for release in a QC/GMP environment for FDA Biologics License Applications (BLA)
• Work cross‑functionally to support CMC activities and regulatory filings on all products, including drafting relevant sections and answers to questions from health authorities
• Analytical Method Development/Validation – Quality by design (QbD), design of experiment (DOE), method qualification and validation per ICH guidelines, development of cell‑based potency assays for engineered T cell drug products and viral vectors, generation of QC‑appropriate cell and viral vector‑based internal positive controls, establishment of critical reagent qualification programs
• Product Quality Systems – Target product profile (TPP/QTPP); development of phase‑appropriate analytical methods for understanding process parameters, and product and material attributes; risk‑based approaches (PQRA) to assigning critical quality/material attributes (CQA/MQA) and critical process parameters (process FMEA); implementation of analytical control strategies

What We Look For

• Multi‑year experience with the above

Who we are

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that's supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically‑optimized BCMA‑targeted chimeric antigen receptor T (CAR‑T) cell therapy NXC‑201 with a proprietary CD3ζ, CD8 hinge and binder "digital filter" designed to filter out non‑specific activation. NXC‑201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC‑201 is being evaluated in the U.S. multi‑center study for relapsed/refractory AL Amyloidosis NEXICART‑2 (NCT06097832), with a potentially registrational design. NXC‑201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.