Job Title: Cell & Gene Therapy Associate

Job Description

• 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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

• This role is based in clinical manufacturing laboratories and cellular therapy clean rooms, where work is performed under strict GMP and aseptic conditions.
• The associate joins a large team of operators and reports into operations leadership, receiving extensive