Manufacturing Associate - Cell Therapy Manufacturing; GMP

Manufacturing Associate - Cell Therapy Manufacturing (GMP) page is loaded## Manufacturing Associate - Cell Therapy Manufacturing (GMP) locations:
Cancer Cell Center (CCC) time type:
Full time posted on:
Posted Todayjob requisition :
R-20349##
*
* Title:

** Manufacturing Associate - Cell Therapy Manufacturing (GMP)
** 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:

** Join a mission-driven team at the forefront of cutting-edge cell and gene therapies. At Roswell Park’s state-of-the-art GMP Engineering & Cell Manufacturing (GEM) Facility, we are pioneering advanced immunotherapies like CAR-T with the goal of transforming patient care.
We are seeking a Manufacturing Associate to play a key role in the clinical manufacturing of cell therapy products. This is a hands-on, lab-based position within a dynamic cGMP environment, ideally suited for individuals passionate about cellular therapeutics and high-impact translational research.

Key Responsibilities:

• Execute end-to-end cell manufacturing processes under cGMP conditions to produce clinical-grade CAR-T and other advanced therapy products.  
• Collaborate cross-functionally with Manufacturing Sciences, Process Development, and Quality Assurance teams to ensure seamless technology transfer, facility fit assessments, and process risk evaluations.  
• Contribute to continuous improvement initiatives to optimize processes and ensure readiness for clinical trial demands and regulatory audits.  
• Maintain accurate, real-time documentation to uphold data integrity and traceability in line with cGMP and institutional requirements.

What You’ll Bring :  
• A strong foundation in cell culture and aseptic technique, ideally in a cGMP or regulated environment.  
• A detail-oriented mindset with a commitment to quality and operational excellence.  
• Effective communication and teamwork skills to support cross-departmental projects.  
• Adaptability and drive to work in a fast-paced, evolving field at the intersection of science and medicine.

• Be part of a nationally recognized cancer center with a legacy of innovation and patient-centered care.  
• Access to world-class facilities, resources, and training to support your professional growth.  
• The opportunity to directly contribute to life-saving therapies that make a difference in patients’ lives.
Responsibilities:  
• Manufacture Cell Therapy Products:
Perform end-to-end production activities for CAR-T and other advanced cell therapies in a cGMP-compliant cleanroom setting, following strict protocols and aseptic techniques.  
• Execute Unit Operations:
Follow approved batch records and SOPs to carry out core processes including cell culture, aseptic processing, and cryopreservation activities.  
• Document to cGMP Standards:
Maintain real-time, compliant documentation in alignment with Good Documentation Practices (GDP) to ensure full traceability and audit readiness.  
• Operate & Maintain Equipment:
Set up, operate, and perform routine maintenance on specialized laboratory and production equipment, ensuring consistent and reliable performance.  
• Support Documentation & Process Development:
Contribute to the review, editing, and approval of SOPs, batch records, protocols, and technical reports to support technology transfer and process improvement.  
• Cross-Functional Teamwork:
Work collaboratively with GEM teams including Manufacturing Sciences, Quality Assurance, and Process Development to meet production goals and resolve technical challenges.  
• Drive Operational Excellence:
Actively contribute to continuous improvement initiatives, using insights from day-to-day operations to propose enhancements in efficiency, safety, and compliance.  
• Handle Biological Materials Safely:
Work with human-derived materials under containment protocols, using appropriate PPE and biosafety procedures.  
• Support Flexible Scheduling:
Adjust to changes in production schedules and support shifts, as needed, to meet clinical…