Research Associate- GMP Cell Manufacturing Process Development

Roswell Park Comprehensive Cancer Center

1d•$62,514 - $78,846•Onsite

About The Position

Support the development, optimization, and transfer of GMP-compliant CAR T-cell manufacturing processes from leukapheresis material through final product cryopreservation. Execute hands-on cell therapy process development activities, including T-cell isolation, activation, genetic modification, expansion, harvesting, formulation, and cryopreservation using automated and semi-automated manufacturing platforms such as CliniMACS Plus, CliniMACS Prodigy, and G-Rex systems. Perform laboratory studies to evaluate process performance, scalability, robustness, and technology transfer readiness while maintaining aseptic techniques and compliance with GMP principles. Conduct analytical testing, including flow cytometry and cell-based assays, to assess cell phenotype, viability, potency, and function, and document results to support process characterization, continuous improvement, and manufacturing readiness.

Requirements

Master’s degree and the equivalent of eighteen (18) months of full-time professional research experience in a laboratory, clinical or scientific research environment; or
Bachelor’s degree and the equivalent of thirty (30) months of full-time professional research experience in a laboratory, clinical or scientific research environment.
Degrees must be conferred by an accredited school, college, or university, or by an institution recognized by Roswell Park Comprehensive Cancer Center and/or Health Research Incorporated as adhering to acceptable educational standards.

Nice To Haves

Familiarity with CAR T-cell manufacturing workflows, including leukapheresis processing, T-cell isolation, activation, gene modification, expansion, harvesting, formulation, and cryopreservation.
Knowledge of commonly utilized tools in cell therapy or blood processing laboratories (examples CliniMACS Plus and CliniMACS Prodigy, Cocoon). Including: Blood Processing techniques - Manual Ficoll, CliniMACS Plus / CliniMACS Prodigy, PCR/ qPCR).
Experience in GMP manufacturing
Knowledge of FACT, cGMP, and FDA biologics regulations
Familiarity with technical documentation, Standard Operating Procedures (SOP), Batch Record (BR) and report writing

Responsibilities

Support the development, optimization, and transfer of GMP-compliant CAR T-cell manufacturing processes from leukapheresis material through final product cryopreservation.
Execute hands-on cell therapy process development activities, including T-cell isolation, activation, genetic modification, expansion, harvesting, formulation, and cryopreservation using automated and semi-automated manufacturing platforms such as CliniMACS Plus, CliniMACS Prodigy, and G-Rex systems.
Perform laboratory studies to evaluate process performance, scalability, robustness, and technology transfer readiness while maintaining aseptic techniques and compliance with GMP principles.
Conduct analytical testing, including flow cytometry and cell-based assays, to assess cell phenotype, viability, potency, and function.
Document results to support process characterization, continuous improvement, and manufacturing readiness.
Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.