Melissa Gallardo Email & Phone Number

Northbrook, Il, Us

Program and protocol lead for zolbetuximab. CSC lead for Autologous Cell Therapy clinical study. BPO for SmartSupplies forecasting tool. Support process improvement initiatives involving Early Access/Post-Trial Access, commercial drug sourcing, reconciliation and destruction, etc.

-Drug Product Planner Program level Oversight and CSC lead for zolbetuximab P3 Pivotal trial-Drug Supply Lead for Early Access Medicine for 900+ patients across 20 countries -Drug Supply Lead and SME for Autologous Cell Therapy Clinical study end to end COI and COC-Business Owner for Smart Supplies Forecasting tool-Proficient in process improvement, program/product management, risk management and strategic management -Experience with direct interface with FDA inspector during sponsor inspections

-Program and Protocol level supply and demand forecasting and planning for high profile oncology studies.-Business owner and Global SME for SmartSupplies Forecasting-Manage complex Phase 3 zolbetuximab clinical study participating in over 20 countries, including China, Israel, and others. -Program level Drug Product Planner oversight to ensure stable supply for multiple ongoing studies running in parallel. -Clinical Supply Chain Lead for Cell and Gene Therapy (Autologous) clinical study

- Responsible for independent planning and management of clinical supplies for Astellas clinical studies.- Effective forecasting and planning of all aspects of packaging activities and inventory management.- Coordinate with external vendors, clinical supply packagers, QA/QC, Regulatory, and other groups within Astellas to ensure accurate and timely support for clinical supplies.- Plans and manages for demanding inventory management models using IVRS.- Manages inventory, drug expiration, returned goods documentation, and contract review efficiently.

Implemented an Inspection Readiness Program. Efficient interface with FDA and Internal Audits. Manage Product Complaint Program. Process incoming complaints, perform extensive review of Supplier investigation reports. Developed and manage significant quality metrics. Support the Supplier Evaluation Program. Established and manage a formal Management Review Program. Developed the SOP, Management Review Form and Management Review Scorecard to monitor Key Performance Indicators (KPI). Maintain the Global Change Control Program and request assessment from appropriate Regulatory groups. Decreased overall turn around time for completion dramatically by 60%. Support Supplier Evaluation Program, Quality Business Reviews and Product Recall. Developed WPDs for Exception Management.

Chicago, Il, Us

Naperville, Il, Us

Quality Assurance Product Complaint Analyst. Responsibilities include metric and trending assistance. Involved in process mapping of systems to reflect current practices. Responsible for training other Analyst.