About This Role
This vital role serves as a Clinical Supply Chain individual contributor, supporting Development Supply Chain Leads (DSCLs) in executing end-to-end clinical supply activities. The position ensures reliable patient drug supply across Amgen's global clinical trial portfolio and provides hands-on operational and technical support across New Product Introductions (NPIs), SAP workflow execution, material master and SKU lifecycle management, documentation workflows, and process improvement. It is an execution-oriented individual contributor role with broad cross-functional exposure across the clinical supply network.
Responsibilities
- Serve as a primary operational support partner for DSCLs, helping execute clinical supply chain activities across programs and studies
- Establish, maintain, and use structured intake, triage, tracking, and follow-up processes for DSCL requests to improve transparency, prioritization, and execution discipline
- Support risk identification, issue triage, timely escalation, and closure of operational requests in partnership with DSCLs and global stakeholders
- Manage multiple priorities and interdependencies while maintaining strong execution against agreed timelines
- Support NPI activities for Not for Human Use (NHU) device, NHU packaging, and GMP bulk pack Drug Product workflows
- Coordinate and execute SAP process work order (PWO) conversions for bulk clinical Drug Product and NHU device/packaging orders in accordance with established procedures
- Manage SAP material creation, SKU lifecycle management, and obsoletion workflows for DSCL-owned SKUs, ensuring data accuracy, traceability, and compliance
- Partner with relevant functions to resolve data, workflow, or execution issues that may affect clinical supply readiness
- Manage clinical product temperature excursion support form workflows, including authorship, routing, documentation, and follow-up in Veeva Vault as applicable
- Centralize and maintain shipment requirement updates and transportation lane requests in partnership with Global Distribution
- Support deviation, change control, CAPA, and risk assessment activities within the site framework, as capacity and access allow
- Maintain documentation quality and inspection readiness by following applicable GMP/GDP, GxP, regulatory, and Amgen procedural requirements
- Partner with DSCLs, Product Delivery Teams, Manufacturing, Global Supply Chain, Global Distribution, Quality, and other stakeholders to support end-to-end supply readiness
- Participate in NPI, planning, and cross-functional meetings to represent DSCL operational needs, actions, risks, and follow-ups
- Communicate operational status, risks, decisions, and dependencies clearly to stakeholders across regions and time zones
- Support timely coordination of actions that help mitigate supply, data, documentation, and execution risks
