The Manufacturing Associate will play a crucial role in the production of CAR-T cell therapies. This position involves working within a controlled environment to support the upstream processes, including cell culture, expansion, and quality control of cells. The ideal candidate will have a strong background in cell biology and experience in manufacturing or laboratory settings.
Key Responsibilities:
Cell Culture: Perform routine and non-routine cell culture procedures for T cell expansion, ensuring optimal growth conditions and sterile techniques.
Process Execution: Follow established protocols for upstream manufacturing processes, including media preparation, cell seeding, and maintenance of bioreactors.
Quality Control: Conduct in-process testing and quality checks to ensure compliance with regulatory standards and company policies.
Documentation: Maintain accurate and detailed records of experiments, procedures, and outcomes in compliance with Good Manufacturing Practices (GMP).
Equipment Maintenance: Assist in the operation and maintenance of bioreactors and other upstream manufacturing equipment, ensuring functionality and cleanliness.
Collaboration: Work closely with cross-functional teams, including Quality Assurance, Process Development, and Regulatory Affairs, to support project goals.
Problem-Solving: Identify and troubleshoot issues in the manufacturing process, contributing to continuous improvement efforts.
Training: Participate in training programs and assist in training new team members on manufacturing procedures and safety protocols.
Qualifications:
Bachelor's degree in Biological Sciences, Biotechnology, or a related field; or equivalent experience in a laboratory setting.
Experience in cell culture techniques, particularly with T cells or immune cells, is highly desirable.
Familiarity with GMP regulations and quality systems in a manufacturing environment.
Strong attention to detail and ability to follow complex protocols.
Excellent communication and teamwork skills.
Ability to work in a fast-paced environment and manage multiple tasks effectively.
Physical Requirements:
Ability to work in a laboratory environment, including the use of personal protective equipment (PPE).
Capability to lift and move equipment and materials as needed (up to 25 lbs).