Buyer/Planner (GMP)

Buyer/Planner (GMP) I

Job Summary: Talent Software Services is in search of a Buyer/Planner (GMP) for a contract position in Novato, CA. The opportunity will be seven months with a strong chance for a long-term extension.

Position Summary: The role serves as an integral member of the Global External Operations team, with a key responsibility for readiness in external contract manufacturing activities related to commercial drug products. The position involves the coordination of starting material, drug product, and finished packaged goods supply needs between contract manufacturers and internal teams to ensure all commercial and clinical needs are defined and met. The candidate will work closely with a cross-functional team and coordinate activities between Supply Chain, Operations, Quality, Logistics, TDS, and the contract manufacturer, reporting to the Director of Supply Chain Operations.

Primary Responsibilities/Accountabilities:

• Process Team Member and Support
  • Act as the communication conduit between the CMO and internal process teams and other departments to meet the supply plan.
  • Analyze, issue, and execute the production plan with the CMO to ensure an uninterrupted supply of clinical and commercial products.
  • Identify supply constraints and negotiate/resolve issues with the CMO to meet the supply plan.
  • Coordinate activities in the evaluation/execution of issues, process changes, change requests, and deviations to ensure timely resolution without impacting supply.
  • Maintain process order dates to match CMO order confirmations and schedule changes to support supply plan visibility and master scheduling.
  • Manage shipment requests, coordination, inbound & outbound shipments, and bulk packs & samples.
  • Manage ERP aspects for purchasing and production efforts at the CMO.
• Purchase Order Management
  • Create, submit, and confirm supplier orders.
  • Allocate materials and maintain dates, costing, and materials through closure.
  • Oversee and maintain associated condition records in ERP.
  • Ensure on-time supplier and vendor payment upon invoice.
• Process Order Management
  • Convert planned orders to process orders per production planning.
  • Maintain process order dates and allocations.
• Shipment Planning and Management
  • Manage all shipments within the network.
  • Create and execute 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 substances, drug products, finished goods, and components at the CMO site.
  • Determine order requirements using ERP MRP, Min Max system, and other electronic reporting tools (consumption, scheduling).
  • Manage materials outside of the ERP system.
  • Establish and maintain relationships with suppliers.
  • Analyze and resolve purchase order and invoice issues.

Qualifications:

• Minimum of 3-5 years in Operations or Supply Chain.
• BS/BA degree in life sciences, business, or supply chain management.
• Ability to guide and support cross-functional teams in resolving short-term issues and achieving long-term goals.
• Experience with CAPA, FMEA, and RCA tools in a highly regulated manufacturing environment is desired.
• Strong written and verbal communication skills, commercial acumen.
• High level of initiative and questioning skills, along with strong organizational skills.
• Experience in supply planning or inventory management.
• Strong understanding of ERP/MRP systems and processes (Knowledge of SAP is preferred).