The Lead GMP Specialist, executes daily operations within a Cell and Gene Therapy GMP facility. This position involves working with advanced CGT manufacturing processes, ensuring compliance with Good Manufacturing Practices (cGMP), and delivering high-quality clinical-grade CGT products. The role includes troubleshooting issues, training and mentoring junior staff. Perform aseptic manufacturing of cell and gene therapy products in accordance with SOPs, batch records, and cGMP guidelines. Operate equipment for cell processing, including selection, activation, expansion, formulation, and cryopreservation. Conduct routine maintenance and perform preventive checks on manufacturing equipment. Assist in developing manufacturing schedules and ensure timely completion of production tasks while maintaining high standards of accuracy and quality. Assist with equipment commissioning, qualification testing, and process validation activities with Facility, QC, and QA teams.

Directs day-to-day laboratory operations while ensuring compliance with safety regulations and best practices. Works with, adapts, and installs scientific equipment in research laboratories. Develops moderately complex projects and procedures independently. Manages inventory and equipment and performs budget functions. Collaborates to write grant applications and manuscripts.

Directs day-to-day laboratory operations while ensuring compliance with safety regulations and best practices. Works with, adapts, and installs scientific equipment in research laboratories. Develops moderately complex projects and procedures independently. Manages inventory and equipment and performs budget functions. Collaborates to write grant applications and manuscripts.

The Lead GMP Specialist, executes daily operations within a Cell and Gene Therapy GMP facility. This position involves working with advanced CGT manufacturing processes, ensuring compliance with Good Manufacturing Practices (cGMP), and delivering high-quality clinical-grade CGT products. The role includes troubleshooting issues, training and mentoring junior staff. Perform aseptic manufacturing of cell and gene therapy products in accordance with SOPs, batch records, and cGMP guidelines. Operate equipment for cell processing, including selection, activation, expansion, formulation, and cryopreservation. Conduct routine maintenance and perform preventive checks on manufacturing equipment. Assist in developing manufacturing schedules and ensure timely completion of production tasks while maintaining high standards of accuracy and quality. Assist with equipment commissioning, qualification testing, and process validation activities with Facility, QC, and QA teams.