Job Details

Biotechnology & Pharmaceutical Research & Development | Regulatory Affairs

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Responsibilities:

• Process Team Member and Support Act as the focus and conduit for communications between the CMO and with members of the 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 client 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.
• Purchase order and invoice issue analysis and resolution.

Qualifications:

• Minimum requirement of 3-5 years in Operations or Supply Chain BS/BA degree; life sciences, business, or supply chain management.
• 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.
• 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.
• Strong understanding of ERP/MRP systems and processes (Knowledge of SAP is preferred)

This role is not eligible for C2C.

Seniority level

• Associate

Employment type

• Contract

Job function

• Finance

Industries

• Biotechnology Research and Pharmaceutical Manufacturing