CAR T Manufacturing Scientist

Required Skills & Experience

• Bachelor’s degree in Biology, Biochemistry, Bioengineering, Biotechnology, or a related scientific discipline.
• 2+ year of hands-on experience with cell culture and aseptic techniques.
• Experience performing hands-on cell processing or manufacturing activities.
• Experience working with primary immune cells or T-cell culture.
• CAR-T, cell therapy, or closely related biologics experience.
• Understanding of GMP principles, controlled documentation, and quality requirements.
• Experience with cell cryopreservation, including formulation, freezing, and transfer to storage.
• Ability to work effectively in a fast-paced, highly documented manufacturing environment.

Nice to Have Skills & Experience

• Direct autologous CAR-T manufacturing experience.
• 3+ years of relevant cell therapy, biotechnology, or biologics manufacturing experience.
• Previous GMP manufacturing or GMP laboratory experience.
• Experience with LOVO, Cue, Xuri, Sefia, Prodigy, or similar cell-processing platforms.
• Experience using electronic batch records or other electronic GMP documentation systems.
• Experience with flow cytometry.
• Experience with LN2 freezers and cryogenic sample handling.
• Experience supporting audits or regulatory inspection readiness.
• Exposure to manufacturing automation, data science, or AI initiatives.

Job Description

Our large pharmaceutical client is seeking a Manufacturing CAR-T Scientist to support hands-on autologous CAR-T manufacturing operations in a GMP environment. This scientist will work directly on the manufacturing floor performing aseptic cell processing activities throughout the CAR-T manufacturing workflow. The role requires strong attention to documentation, organization, and GMP compliance while executing time-sensitive manufacturing activities in a highly collaborative environment.

Key Responsibilities

• Perform hands-on CAR-T manufacturing and cell processing activities within a GMP cleanroom environment.
• Execute key stages of the autologous CAR-T process, including T-cell selection, activation, cell culture, washing, formulation, cryopreservation, and final processing.
• Perform aseptic processing using biological safety cabinets and single-use or semi-automated manufacturing systems.
• Prepare materials, equipment, and the cleanroom environment prior to manufacturing activities.
• Follow established batch records, SOPs, manufacturing procedures, and GMP requirements.
• Document manufacturing activities accurately within electronic batch record systems and maintain complete GMP documentation.
• Perform manufacturing verifications and communicate deviations, processing issues, or unexpected events to appropriate team members.
• Support cell formulation, freezing, transfer, and cryogenic storage activities using LN2 storage systems.
• Utilize cell-processing equipment that may include LOVO, Cue, Xuri, Sefia, Prodigy, or comparable systems.
• Support primary immune cell culture and aseptic transfer of cellular materials throughout the manufacturing process.
• Maintain strict cleanroom, gowning, contamination-control, cleaning, and waste-disposal practices.
• Support team training and execution of manufacturing procedures.
• Collaborate across Manufacturing, Quality, Process Development, and other technical groups to resolve issues and maintain production timelines.
• Participate in additional projects based on experience, including audit support, inspection readiness, automation, scientific studies, data science, or AI initiatives.