Lorenzo Scarafone

Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring
compliance with all cGMP and safety standards.
• Execute complex procedures for cell therapy manufacturing and sterile product operations -
including cell culture, formulation, and cryopreservation - while maintaining strict adherence to
written procedures, batch records, and cGMP regulations.
• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and
functionality.
• Monitor and document all production processes with precision, ensuring traceability and
compliance with regulatory standards.
• Identify and escalate deviations or non-conformances; participate in root cause analyses and
implement corrective actions.
• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to
support continuous improvement initiatives.
• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and
sterilization activities.
• Maintain an organized, compliant workspace by following 5S principles and minimizing
contamination risks.
• Participate in training sessions to stay current with manufacturing techniques, quality standards,
and safety protocols.
• Support process development activities during technology transfer.
• Aseptically gown and work in Grade A, B, and C cleanroom environments and stand for extended
periods.
• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records
(MBRs).
• Review MBRs daily to ensure documentation is accurate and complete.
• Participate in audits, inspections, qualifications, and validation activities.
• Handle chemicals such as corrosives, solvents

• Operated and maintained production machinery to ensure efficient workflow and minimize downtime.

• Collaborated with team members to troubleshoot equipment malfunctions, enhancing operational efficiency.
• Monitored quality control processes, ensuring compliance with safety and regulatory standards.
• Downstream processing involving Harvest → Clarification → Chromatography → Filtration/Formulation

• Performed GMP manufacturing operations supporting radioligand therapy production
• Executed validated manufacturing processes and ensured accurate batch documentation
• Identified and escalated deviations and non-conformances supporting QA workflows
• Maintained compliance with radiation safety and aseptic handling procedures

• Executed GMP manufacturing of autologous CAR-T cell therapy products in aseptic cleanroom environments
• Performed batch record execution under strict cGMP and SOP compliance requirements
• Supported deviation investigations with QA, including documentation and initial impact assessment
• Served as qualified trainer onboarding new manufacturing operators in aseptic technique and GMP procedures