Research Associate- GMP Cell Manufacturing Process Development

roswellpark; United States; On-site; USD 63,000 - 79,000; Full time

Job summary

Health Research, Inc. (HRI) Roswell Park Division is seeking a Research Associate to support GMP CAR T-cell process development.

You will execute T-cell isolation, activation, genetic modification, expansion, harvesting, formulation, and cryopreservation on automated platforms, contributing to technology transfer. The role includes conducting flow cytometry and cell-based assays to evaluate phenotype, viability, potency, and function, with documentation to support process characterization and

Qualifications

• Master's degree or equivalent combined with research experience in a lab setting.
• Experience in CAR-T workflows and GMP manufacturing environments.
• Familiarity with SOPs, BRs and regulatory documentation.

Responsibilities

• Support development, optimization, and transfer of GMP CAR T-cell processes.
• Perform T-cell isolation, activation, gene modification, expansion, harvesting and cryopreservation.
• Conduct analytical testing (flow cytometry, cell-based assays) and document results.
• Maintain aseptic technique and GMP compliance throughout manufacturing activities.

Skills

CAR T-cell workflows

GMP manufacturing

Regulatory knowledge (FDA)

Technical documentation

Education

Master's degree in a relevant field

Bachelor's degree + 30 months research experience

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)

Summary

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.

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.

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

RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and 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.