Associate Director, Warehouse Operations
Current* Responsible for R&D, Clinical, and Manufacturing international/domestic logistics as well as the selection, contracts, invoice reviews/approvals, and management of courier relationships.* Management of product receipt and storage of GMP/GLP biologic/device products in monitored/controlled GMP facilities (in-house and 3rd Party 3PL’s and CMO’s)* Coordinated with Clinical/R&D for planning, roll-out, and completion of multiple preclinical, phase 2, and phase 3 clinical trials supporting oncology and infectious disease therapies for drug/device combination platform * Supported Clinical shipments, returns, excursions, complaints, trial completion, and TMF reconciliation* Assisted in trial startup activities including collaborating with CRO’s, helping to develop forecasts, developing/testing IRT systems, and facilitating Clinical training needs* Company CDC representative for audits/licensure/permits/compliance; managed USDA Import Permits process* Management of international/domestic GLP/GMP biologic and medical device product shipments of controlled ambient, cold pack, and LN2 products including PBMC's, DNA plasmids, and clinical devices* Project managed the selection/implementation of Microsoft Dynamics 365 ERP system within timeline (six months), under budget (7%), and in compliance with 21 CFR Part 11 requirements (CSV-based validation)* Project management responsible for the selection, implementation, and overall management of 3PL* Project management of D365 ERP system enhancements, version updates, and associated validation* Developed and implemented materials management strategy for change from clinical to commercial operations moving from hundreds to hundreds of millions of devices in less than two years* Maintained staff/performance levels and materials/logistics support of international clinical trials for COVID initiatives that worked with the DoD, WHO, and other government-level partners