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.

Responsibilities

• 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 platforms (e.g., CliniMACS Plus, CliniMACS Prodigy, G-Rex).
• Perform laboratory studies to evaluate process performance, scalability, robustness, and technology transfer readiness while maintaining aseptic techniques and GMP compliance.
• Conduct analytical testing (e.g., flow cytometry, cell-based assays) to assess cell phenotype, viability, potency, and function.
• Document results to support process characterization, continuous improvement, and manufacturing readiness.
• Comply with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables.

Requirements

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

Qualifications

• Familiarity with CAR T-cell manufacturing workflows, including leukapheresis processing, T-cell isolation, activation, gene modification, expansion, harvesting, formulation, and cryopreservation.
• Knowledge of tools used in cell therapy or blood processing laboratories (e.g., CliniMACS Plus, CliniMACS Prodigy, Cocoon).
• Experience with blood processing techniques (e.g., manual Ficoll, CliniMACS Plus/Prodigy, PCR/qPCR).
• Experience in GMP manufacturing.
• Knowledge of FACT, cGMP, and FDA biologics regulations.
• Familiarity with technical documentation, Standard Operating Procedures (SOP), Batch Records (BR), and report writing.

Pay

The salary range for this position is $62,514 – $78,846 annually. The actual offer may vary based on qualifications, skills, and experience.

Benefits

Comprehensive benefits package included.

Schedule

• Full time (1.0 FTE).
• 40 hours per week.
• First shift.