Immix Biopharma, Inc. Cell Therapy Analytical Method Validation Lead (Associate Director) Los Angeles, CA · Full time Company website

Apply for Cell Therapy Analytical Method Validation Lead (Associate Director)

Qualifications

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

Our Values

·        Integrity

·        Intelligence

·        Initiative

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.

Job Type: Full-time

Benefits:

·        Health insurance

·        401k

Schedule:

·        Full time

Experience:

·        Pharma or CAR-T

Language:

·        English