Job Details

The Supply Chain Operations Specialist serves as an integral member of the Global External Operations team who has responsibility for and plays a key role in readiness for external contract manufacturing activities relating to commercial drug products. They help coordinate starting material, drug product and finished packaged goods supply needs between contract manufacturers and internal teams to ensure that all commercial and clinical needs are defined and met. The candidate is required to work closely with a cross-functional team and coordinate activities between Supply Chain, Operations, Quality, Logistics, TDS and the contract manufacturer. The GEO Supply Chain Operations Specialist reports to the Director, Supply Chain Operations, GEO

KEY RESPONSIBILITIES

Process Team Member and Support

• Act as the focus and conduit for communications between the CMO and with members of Process Teams and other departments to meet the supply plan
• Analyze, issue and execute with the CMO the production plan to deliver an uninterrupted supply of clinical & commercial product
• Identify any supply constraints and negotiate/resolve with the CMO any issues to meet the supply plan
• Coordinate company activities in the evaluation/execution of issues, process changes, change requests and deviations to ensure timely resolution without impacting on supply
• Commit Process – maintain process order dates to match CMO order confirmations and changes in schedule to support supply plan visibility and master scheduling
• Shipment Management – request submission, shipment coordination, inbound & outbound, DS/DP/bulk packs & samples
• Manage ERP aspects for purchasing and production efforts at CMO
• Purchase Order Management
• Creation, submission, and supplier confirmation
• Material allocations
• Maintenance of dates, costing, and materials through closure
• Oversight and maintenance of associated condition records in ERP
• Ensure on-time supplier and vendor payment upon invoice
• Process Order Management
• Convert planned to process orders per production planning
• Process order maintenance of dates and allocations
• Shipment Planning and Management
• Manage of all shipments within the network
• Creation and execution of STR/STO in SAP
• Lead cross-functional coordination and visibility for shipments
• Material Requirements Planning (MRP) and Management
• Monitor and manage inventory levels of drug substance, drug product, finish goods and components as applicable at the CMO site
• Determine order requirements thru use of ERP MRP, Min Max system and other electronic reporting tools (consumption, scheduling)
• Management of materials outside of ERP system
• Establish and maintain relationships with suppliers
• Problem Solving
• Lead and conduct RCARs for issues and continuous improvement within area
• Other duties as assigned

EDUCATION AND EXPERIENCE

• Minimum requirement of 3-5 years in Operations or Supply Chain
• BS/BA degree; life sciences, business, or supply chain management
• Will have a good understanding of the processes/unit operations assigned to the team.
• Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
• Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
• Strong written and verbal communication, commercial acumen.
• A high level of initiative and questioning skills are key role requirements, as well as strong organizational skills.
• Experience in supply planning or inventory management.
• Experience in inventory reconciliation.
• Working knowledge of GXP regulations.
• Strong understanding of ERP/MRP systems and processes (Knowledge of SAP is preferred)