Cell Production Specialist

Major responsibilities

• Participate in preparation work for CAR-T cell therapy drug production.
• Engage in CAR-T cell therapy drug manufacturing operations and accurately complete all required documentation.
• Assist in or be responsible for drafting, revising, and version upgrading of CAR-T cell therapy-related documents including SOPs and batch records.
• Participate in or lead the preparation and revision of change control documents for CAR-T cell therapy drugs;
• Take part in necessary GMP facility maintenance, equipment cleaning, and validation activities;
• Strictly comply with the company's Quality Management System requirements and implement them in daily operations Complete other assigned tasks.

Education, Qualifications, Skills And Experience

• Bachelor's degree or higher in Cell Biology, Molecular Biology, Bioengineering or related fields;
• Solid theoretical knowledge in cell biology with practical operational experience;
• Proficient in cell culture techniques, gene transduction, and aseptic operations;
• Fundamental understanding of GMP drug production principles; prior experience in cell therapy manufacturing is preferred;
• Ability to proactively summarize production experience and independently troubleshoot issues;
• Strong sense of responsibility and teamwork spirit with quick adaptability to new environments;
• Have excellent communication skills to ensure accurate and efficient cross-departmental information exchange.