Car-T Cell Therapy Manufacturing Associate

About the Role

The Car-T Cell Therapy Manufacturing Associate is a full-time, on-site role responsible for performing day-to-day manufacturing operations for CAR-T cell products. This includes aseptic handling of cell cultures, execution of batch production steps, and adherence to defined standard operating procedures (SOPs).

Key Responsibilities

• Work in classified clean rooms.
• Prepare materials and equipment for production runs.
• Record manufacturing data accurately.
• Support in-process quality checks.
• Collaborate with quality control, quality assurance, and process development teams to ensure compliance with Good Manufacturing Practice (GMP) and internal safety standards.
• Assist with equipment maintenance.
• Assist with environmental monitoring.
• Assist with continuous improvement initiatives to enhance productivity and product consistency.

Requirements & Tech Stack

• Skills in clean room operations and aseptic techniques.
• Skills in manufacturing operations, including handling production equipment and following SOPs.
• Skills in Good Manufacturing Practice (GMP), including regulatory awareness and adherence to quality standards.
• Skills in quality control, including basic analytical understanding and support for deviation investigations.
• Strong communication skills to collaborate effectively with cross-functional teams and report operational issues clearly.
• Ability to follow safety protocols.
• Ability to work in shifts if required.
• Ability to maintain high attention to detail.

Qualifications

• Bachelor’s degree or diploma in biotechnology, biochemistry, microbiology, pharmaceutical sciences, or a related field is preferred.
• Prior experience in biopharmaceutical, cell therapy, or sterile manufacturing environments is beneficial.