Research Associate- GMP Cell Manufacturing Process Development

Research Associate- GMP Cell Manufacturing Process Development

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. The salary range for this position is $62,514 - $78,846 annually which includes a comprehensive benefits package. The actual offer may vary based on qualifications, skills, and experience.

Required

Education and Experience 1. 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 2. Bachelor's degree and the equivalent of thirty (30) months of full-time professional research experience in a laboratory, clinical or scientific research environment.

NOTE:

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.

• 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