This role leads the discovery, engineering, and development of next-generation cellular therapies including auto/allo/in vivo CAR-T products for solid and hematologic tumors
Job Summary
This role leads the discovery, engineering, and development of next-generation cellular therapies including auto/allo/in vivo CAR-T products for solid and hematologic tumors.
The successful candidate will own virus process development from upstream production to downstream purification while ensuring scalability and robustness.
Key responsibilities include establishing and qualifying analytical methods for identity, potency, vector copy number, and safety testing in compliance with GxP regulations.
Matching Summary
This role leads the discovery, engineering, and development of next-generation cellular therapies including auto/allo/in vivo CAR-T products for solid and hematologic tumors.
Skills & Requirements
Must-have
Cell therapy process development
CMC expertise for cell therapies
LVV upstream and downstream development
CAR-T cell manufacturing unit operations
Analytical method validation for cell products
Flow cytometry and potency assays
Cross-functional collaboration with CDMOs
Nice-to-have
Design of Experiments (DoE) for process characterization
Cost of Goods optimization strategies
Regulatory submission experience for IND/IMPD
Statistical process control application
Supply chain resilience management
Knowledge of FDA/EMA guidelines for cell/gene therapy
Key Requirements
Master's or PhD in Cell/Molecular Biology, Immunology, Bioengineering, or Bioprocess Engineering
Hands-on experience with LVV upstream/downstream development
Proven track record in validating cell therapy analytical methods
Experience with activation, transduction/editing, expansion, and formulation of CAR-T cells
Knowledge of applicable GxP and laboratory/manufacturing regulations