• Performed end-to-end supply chain planning across five clinical trial programs. • Ensured manufacturing schedules were achieved through planning of demand products and starting materials.• Implemented the new Oracle inventory management system while simultaneously managing allocation of inventory via the existing processes. • Collaborated with Quality team on allocation and disposal of materials.• Supported Sales & Operations Planning (S&OP)

• Coordinate all aspects of study participant sample collection including apheresis, shipping, processing, manufacturing and return of investigational product to clinical trial sites.• Interacted daily and in weekly review meetings with the Clinical Operations, Manufacturing, and Quality departments to ensure manufacturing and capacity demand align to meet the needs of clinical operation.• Built and maintained strong relationship with external vendors, especially CROS, Clinical Sites, and IRT.• Prepared international and domestic bills of lading and packing slips, arranging for fully compliant shipping documentation, and personal contact with customs officials to effect release of shipments.• Participate in the development, review and implementation of departmental SOPs and processes.

• Responsible for clinical sample coordination and scheduling between 10 clinical sites, 10 external processing labs and multiple couriers, resulting in assurance of patient delivery timelines .• Identified and trained external processing labs on company specific protocols and sample processing techniques, such as cell isolation from apheresis and whole blood collections.• Revised test methods, SOPs and specialty lab manuals to ensure compliance with GMP regulations. • Provided clear guidance to internal teams and established sample shipment timelines from clinical sites and N2N meetings.

• Performed work on peripheral blood mononuclear cells (PBMC) and plasma isolation of clinical samples in a BSL2 environment.• Maintained biorepository of clinical and research samples in regulated temperatures ranging from -180 to 20 degrees Celsius. • Scheduled and tracked temperature sensitive shipments.• Responsible for accurately receiving and documenting samples in LIMS.• Maintain organized documentation and chain of custody forms.• Revised Standard Operating Procedures (SOP) to meet GLP standards.

• Managed purchasing and delivery of laboratory inventory items.• Maintained positive client and vendor relationships.• Tracked and monitored expiration risk to avoid scrap.

• Operated and maintained Cobas® 8100, automated aliquoting system for blood samples.• Entered accurate patient information into laboratory LIS.• Learned and complied with all HIPAA and privacy laws.• Ensured labels on specimen coincided with patient demographics.• Handled hazardous waste materials in accordance with lab protocol.• Prioritize tasks to achieve optimal and efficient patient care.