Manufacturing Associate - Cell Therapy Manufacturing (GMP)

Roswell Park Comprehensive Cancer Center

3d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in a science-related field; or
• Associate’s degree in a science-related field and the equivalent of two (2) years of full-time laboratory experience; or
• High School Diploma or High School Equivalency Diploma and the equivalent of four (4) years of full-time laboratory experience.
• NOTE: Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.
• Working knowledge of cGMP standards, including experience with production documentation, batch records, and compliance-driven environments.
• Solid foundation in aseptic technique and mammalian cell culture, with a track record of maintaining sterility and culture integrity in high-throughput or regulated settings.
• Strong communication skills, with the ability to convey scientific concepts clearly across cross-functional teams; collaborative, articulate, and committed to scientific excellence.
• Exceptional attention to detail, especially in documentation, cleanliness, and organization—critical qualities for maintaining reproducibility and regulatory compliance.

Nice To Haves

• Familiarity with key tools and systems used in clinical and commercial cell therapy production, including CliniMACS Plus/Prodigy, Cocoon, or comparable platforms.

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 timelines.
• Prepare Materials for Manufacturing: Ensure availability of raw materials, reagents, and components through proper preparation, inventory management, and coordination with materials management.
• Support Audits & Investigations: Participate in internal and external audits, and support deviation and investigation efforts to uphold quality standards.

Benefits

• 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.
• The starting rate for this position is $40,413 and this includes a full comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees