Anthony DiRe

April 2024 – June 2025.

• Supervise and coordinate day-to-day operations in a sterile manufacturing environment, ensuring compliance with cGMP and FDA regulations.
• Lead cross-functional teams to meet production goals and timelines, while maintaining a strong culture of safety and quality.
• Review and approve batch records, deviations, and change controls to support timely release, and product integrity.
• Delegated tasks to employees and monitored accurate and timely completion of tasks to meet project milestones.
• Train and mentor manufacturing staff, reinforcing best practices, and driving continuous improvement initiatives.
• Planned production operations while establishing priorities and sequences for manufacturing processes.

• Supervised a team of 8 – 10 manufacturing technicians daily, maintaining adherence to a demanding production schedule
• Lead all manufacturing for both clinical and commercial activities that met the site’s strategic objectives and was compliant with cGMP’s, safety regulations, and FDA standards
• Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate
• GMP batch review and close-out with Quality Assurance group in a timely manner to ensure batches adhere to established Quality standards
• Identified and supported the implementation of process efficiencies and areas for improvement
• Lead a manufacturing team to identify issues and propose adequate solutions while optimizing the utilization of available resources to ensure production objectives are met.

• Production of clinical biotherapeutic CAR-T cells using aseptic technique and lab equipment
• Provide input on improvement during tech transfer runs including lab layout, material flow, and processing steps
• Utilize Six Sigma and 5S to streamline and strengthen process and manufacturing logistics
• Provide training and guidance for entry-level personnel on manufacturing process including equipment, technique, and organization
• Knowledgeable with cGMP standards, FDA guidelines including IND and BLA applications, and compliance.

• Purified monoclonal antibody (mAb) in a cleanroom environment using ion-exchange and affinity column chromatography and virus removal filtration and tangential flow filtration processes
• Supported the PD group with small-scale column packing and buffer preparations
• Performed cGMP Operations in compliance with SOPs, Master Batch Records (MBRs), and Equipment Qualification Protocols
• Performed Weigh & Dispense and Buffer Preparation as well as manufacturing and validation sampling/in-process testing
• Communicated status, troubleshot processes, and resolved safety and maintenance issues
• Reviewed, revised, and authored new SOPs, Deviations, and Change Controls.

• Prepared all manufacturing buffers and solutions, 1500L and 2000L scale
• Managed day-to-day activities of 4 dotted-line reportable Technicians manufacturing Engineering and Clinical drug product under cGMP conditions in a single-use ISO 7, 8, and Controlled Not Classified (CNC) cleanrooms
• Maintained inventory for manufacturing supplies and chemicals, procuring based on departmental forecasts
• Collaborated with Supervisors to ensure MPRs, SOPs, and other GxP documents were accurate and current
• Calibrated daily equipment such as balances, pH meters, conductivity meters, and osmometers.

• Prepared media and cell cultures in a clean room/sterile area (class 10,000 / 100,000)
• Operated HMI (human machine interface) and OIT (operator interface terminal) to deliver compounded media to cell culture hold tanks or sterile bags, preparing and delivering media samples to Quality Control
• Ensured production and customer requirements met cGMP’s Clinical Production Schedules Buffer Preparation standards
• Cleaned mix tanks, storage tanks, and transfer lines per departmental SOPs and CIP/SIP cleaning
• Prepared buffers and reagents in strict compliance to established SOPs, including ensuring buffer kit batches contain the correct ingredients and ingredient quantities and reviewing documentation (batch records, logbooks, forms)
• Reviewed and revised SOPs based in part on data recorded from logging activities and monitoring processes.