Research Associate- GMP Cell Manufacturing Process Development

Roswell Park Comprehensive Cancer Center; Buffalo (NY); On-site; USD 63,000 - 79,000; Full time

Job summary

Roswell Park Comprehensive Cancer Center is seeking a Research Associate to support GMP CAR T-cell manufacturing process development and transfer from leukapheresis through cryopreservation. You will perform hands-on cell therapy activities using CliniMACS Plus/Prodigy and G-Rex systems, ensuring aseptic technique and GMP compliance.

The role also involves analytical testing like flow cytometry, documenting results for process characterization and technology transfer readiness.

Qualifications

• Master's degree with the equivalent of 18 months of full-time professional research experience or Bachelor's degree with the equivalent of 30 months of full-time professional research experience.
• 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.

Responsibilities

• Develop, optimize, and transfer GMP CAR T-cell manufacturing processes from leukapheresis through final product cryopreservation.
• Perform T-cell isolation, activation, genetic modification, expansion, harvesting, formulation, and cryopreservation on automated platforms.
• Conduct analytical testing including flow cytometry to assess cell phenotype, viability, potency, and function.
• Document results to support process characterization, continuous improvement, and manufacturing readiness.

Skills

CAR T-cell workflows

CliniMACS Plus

CliniMACS Prodigy

Cocoon

GMP manufacturing

FDA regulations

Documentation (SOP/BR)

Flow cytometry

Education

Master's degree

Bachelor's degree

Tools

CliniMACS Plus

CliniMACS Prodigy

Cocoon

Job description

Title: Research Associate- GMP Cell Manufacturing Process Development

Job Type: Regular

Company: Health Research, Inc. (HRI) Roswell Park Division

Department: Center for Immunotherapy

Time Type: Full time

Weekly Hours: 40

FTE: 1

Shift: First Shift (United States of America)

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.

Qualifications

• 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.

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.

Preferred Qualifications

• 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.

Equal Employment Opportunity Statement

Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual's relationship or association with a member of a protected category or any other protected group status as defined by law.

Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans

Reasonable Accommodation Request. RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email [e-mail] and let us know the nature of your request and your contact information.

Our Core Values

• Innovation
• Integrity
• Teamwork
• Commitment
• Compassion
• Respect

Grant Funding

This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

E-Verify Employer

Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.

Welcome to Roswell Park Comprehensive Cancer Center, America's first cancer center founded in 1898 by Dr. Roswell Park. As one of the largest employers in Western New York, Roswell has over 3,300 employees, including over 200 physicians and scientists and 400 nurses. It is a new era at Roswell Park. Leading the way in cancer research, treatment and education for more than a century, today Roswell Park is setting our course for a second century of extraordinary advances in cancer research and treatment. Equipped with the best facilities, the sharpest and most creative minds, and the single objective of curing cancer, we stand on the threshold of historic discovery.