George Dekanoidze

• Manufacture AlloDerm®, a regenerative tissue matrix derived from human cadaver tissue, in a GMP-compliant cleanroom environment.

• Operate independently as lead for a full manufacturing cell, ensuring strict adherence to SOPs, batch documentation, and production timelines.

• Serve as Backup Cell Lead in 2 of 5 manufacturing cells, supporting training, task coordination, and real-time troubleshooting.

• Trained and qualified in aseptic operations within ISO Class 10 (Grade A/B) cleanroom environments.

• Perform sterile operation of large high-pressure autoclave systems and precision human tissue splitting machines in addition to other systems of operations.

• Utilize SAP extensively for batch record documentation, material movement, inventory tracking, and deviation reporting.

• Apply critical aseptic techniques in tissue processing and equipment handling to ensure sterility and product integrity.

• Collaborate with QA and cross-functional teams on batch record reviews, audits, CAPAs, and quality investigations.

• Ensure compliance with FDA regulations, cGMP, and internal quality and safety standards throughout manufacturing processes.

• Participate in continuous improvement initiatives, contributing to increased process efficiency, reduced deviation( NCR/ER) rates, and enhanced safety.

• Directed or coordinated financial or budget activities to fund operations and maximize investments.
• Delegated work to staff, setting priorities and goals.
• Monitored and improved efficiency of processes, team performance, and customer service.