Maria Ladino

Manufactured CAR-T cell therapy treatment in a controlled cleanroom environment, adhering to strict quality standards and regulatory requirements. Promoted to the role of verifier within five months, responsible for ensuring adherence to regulatory and quality standards in a team of over 25 individuals. Proficient in new Manufacturing Execution Systems (MES) during production ramp-up phases. Qualified in ISO-5 Cleanroom, environmental monitoring, fluorescent imaging cytometer, and aseptic technique. Applied analytical chemistry techniques for precise identification of impurities, contaminants, and identity testing in a CGMP setting. Submitted material analyses reports in collaboration with chemists following CGMP format. Analyzed experimental data and provided valuable insights into experiments. Documented detailed medical notes accurately capturing patient information, symptoms, diagnoses, and treatment plans. Served as a liaison between the doctor and over 25 patients. Provided Spanish translation services to facilitate effective communication with Spanish-speaking patients. Demonstrated leadership skills by effectively delegating tasks, providing guidance, and motivating team members to exceed performance targets. Led a team of 5+ employees, providing comprehensive training and guidance. Maintained a strong focus on customer service, ensuring exceptional customer experiences.