Cell Therapy Associate

Position Overview:

We are looking for a hands-on Manufacturing Operations Technician to contribute to the production of advanced cell-based therapies, including CAR-T and TCR-T products. This role will play a key part in executing manufacturing activities in a regulated environment while supporting readiness for clinical production. The position requires working in controlled cleanroom settings and collaborating with cross-functional teams to ensure timely and compliant manufacturing operations.

Key Responsibilities:

• Execute manufacturing processes in accordance with established procedures and regulatory standards within a GMP-controlled environment
• Prepare and maintain cleanroom spaces, ensuring proper setup of materials, tools, and automated processing systems
• Operate specialized cell therapy equipment and support routine production activities
• Follow strict aseptic techniques, gowning protocols, and cleaning procedures
• Assist with implementation and documentation of manufacturing procedures, including SOP development and updates
• Support activities related to facility and equipment readiness, including qualification and setup
• Coordinate with internal teams such as Process Development and MS&T to align production with development needs
• Monitor inventory levels of critical materials and ensure availability for scheduled manufacturing runs
• Document activities accurately and provide updates to leadership on operational status
• Contribute to deviation investigations and resolution as required
• Participate in technology transfer activities for new or updated processes

Required Qualifications:

• High School Diploma with 5+ years of relevant manufacturing experience, or a Bachelor’s degree in a science or engineering field
• Practical knowledge of GMP environments and regulatory expectations for biologics manufacturing
• Experience working in cleanroom settings with exposure to aseptic processing techniques
• Familiarity with general manufacturing equipment and production workflows

Preferred Experience:

• Background in cell therapy or biologics manufacturing
• Hands-on experience with equipment such as automated cell counters, cell processing systems, and sterile welding/sealing tools
• Involvement in CAR-T or similar immunotherapy production environments
• Exposure to deviation handling and GMP documentation practices

Additional Skills & Expectations:

• Ability to work independently and manage assigned tasks with minimal supervision
• Strong problem-solving skills with the ability to address complex operational challenges
• Effective planning and organizational skills in a fast-paced production setting
• Clear communication skills for both written documentation and verbal updates
• Readiness to contribute immediately with minimal onboarding or training