Cell & Gene Therapy Associate

Cell & Gene Therapy Associate

The Cell & Gene Therapy Associate supports clinical manufacturing operations in a cellular therapy facility, working in clean room environments to process cells and samples using aseptic techniques and GMP practices. This role focuses on clean room qualification, cell and tissue culture activities, and preparation of safe and efficacious cell products for clinical use. It is an excellent opportunity for individuals early in their scientific career who are eager to gain hands-on experience, receive extensive training, and grow within a fast-paced, team-oriented environment.

• Assist with clean room qualification activities, including performing burden cleaning to prepare rooms for testing.
• Run supplies and materials to support clean room operation and processing, ensuring that all required items are available when needed.
• Perform aseptic gowning procedures to enter the clean room and participate in qualification and manufacturing activities.
• Work within manufacturing operations to help process cells and samples in accordance with established procedures and quality standards.
• Process cultures, cryopreserve, and manipulate cell products using aseptic technique to maintain product integrity and sterility.
• Follow Good Manufacturing Practice (GMP) standards and adhere to standard operating procedures (SOPs) in all aspects of laboratory and clean room work.
• Support cellular facility operations, including preparation of media and reagents for cell therapy processes.
• Perform any and all processing and testing required to produce and assess safe and efficacious cell therapy products.
• Work in a clean room environment to carry out stem cell preparation and cell/tissue culture activities.
• Handle batch records and support cell processing steps such as cell expansions, volume reductions, depletions, and enrichments.
• Contribute to clinical trial support by executing laboratory and manufacturing tasks that align with clinical protocols and regulatory requirements.
• Communicate effectively within a large team of operators and with operations leadership to coordinate daily activities and priorities.
• Maintain compliance with facility procedures for clean room entry, gowning, and environmental controls.
• Support a fast-paced production environment by adjusting to changing priorities and schedules as needed.

• Experience working within a cell-based biology laboratory, either in an academic or industry setting.
• Hands-on experience with aseptic technique in laboratory or clean room environments.
• Familiarity with GMP practices and the ability to follow SOPs consistently.
• Experience with cell culture, including handling and maintaining cell and tissue cultures.
• Ability to work effectively in a fast-paced environment and adapt to changing operational needs.
• Strong communication skills and the ability to collaborate within a team environment.
• Capability to perform clean room gowning procedures and work comfortably in a controlled environment.
• Experience working with batch records and documented procedures.
• Ability to support processes such as cell expansions, volume reductions, depletions, and enrichments.
• Understanding of basic biology laboratory operations, including media preparation and general lab practices.

• Associate or bachelor's degree in biology or a related scientific field is preferred.
• Bachelor's degree in a scientific discipline is strongly preferred for candidates seeking long-term growth in cell and gene therapy.
• Previous experience in a pharmaceutical, biotechnology, or clinical manufacturing environment is a plus.
• Experience in stem cell preparation and cell/tissue culture is highly beneficial.
• Exposure to clinical trial support activities within a laboratory or manufacturing setting is an advantage.
• Previous experience with lab gowning procedures and working in clean room or controlled environments.
• Demonstrated positive attitude, strong work ethic, and willingness to learn new techniques and processes.
• Ability to manage time effectively and maintain attention to detail in documentation and processing.

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