Role Description

Let's do this. Let's change the world. In this vital role, you will serve as a Clinical Supply Chain individual contributor supporting Development Supply Chain Leads (DSCLs) in the execution of end-to-end clinical supply activities that enable reliable patient drug supply across Amgen's global clinical trial portfolio.

Reporting to the Senior Manager Clinical Supply Chain, you will provide 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. You will work closely with DSCLs, Product Delivery Teams, Manufacturing, Global Distribution, Quality, and other cross-functional partners to ensure work is triaged, executed, documented, and escalated in a compliant and right-first-time manner.

The role is accountable for translating DSCL priorities into disciplined operational execution, improving visibility to requests and risks, and strengthening clinical supply readiness through accurate data, effective issue triage, and continuous improvement. This is an execution-oriented individual contributor role with broad cross-functional exposure across the clinical supply network.

Roles & Responsibilities

DSCL Operational Support & Request Management

• 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.

NPI, Material, and SAP Workflow Execution

• 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.

Documentation, Compliance & Process Control

• 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.

Cross-Functional Collaboration & Supply Readiness

• 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.

Continuous Improvement, Metrics & Digital Enablement

• Contribute to continuous improvement projects that standardize, simplify, or improve DSCL support processes.

• Develop or maintain dashboards, trackers, metrics, and reporting mechanisms that improve visibility to workload, cycle time, backlog, request aging, and right-first-time execution.

• Use data and process insights to identify recurring issues, recommend improvements, and support root cause analysis.

• Support adoption of digital tools, automation, and AI-enabled ways of working where appropriate to improve productivity and service quality.

Functional Skills

Must-Have Skills

• Clinical supply chain, planning, manufacturing, or material management experience in a regulated biopharmaceutical, pharmaceutical, or life sciences environment.

• Hands-on working knowledge of SAP or similar ERP systems, including material master data, order release or conversion workflows, SKU management, and lifecycle updates.

• Strong operational execution skills, including request triage, prioritization, follow-through, documentation discipline, and attention to detail.

• Excellent written and verbal communication skills, including the ability to communicate technical, system, data, and process topics to cross-functional partners.

Preferred Qualifications & Desirable Attributes

• Experience supporting operational execution for clinical supply, manufacturing, planning, New Product Introduction, Drug Product, device, packaging, comparator, or material lifecycle workflows in a regulated environment.

• Demonstrated ability to operate effectively in a matrixed, cross-functional, and global environment, partnering with DSCLs, Product Delivery Teams, Manufacturing, Global Supply Chain, Global Distribution, Quality, Technology, Compliance, and other stakeholders.

• Experience managing multiple priorities, operational interdependencies, request backlogs, and competing timelines while using strong collaboration and influencing skills to drive alignment and outcomes without direct authority.

• Working knowledge of regulated biopharmaceutical, pharmaceutical, or life sciences environments, including GxP, GMP/GDP, documentation practices, deviation/change control/CAPA processes, risk assessments, or inspection readiness.

• Experience using metrics, dashboards, analytics, reporting tools, or data insights to improve workload visibility, support decision-making, identify trends, and drive continuous improvement.

• Experience supporting change initiatives, process improvement, system implementation, digital transformation, automation, AI-enabled ways of working, or user adoption efforts; APICS, ISM, Lean, Six Sigma, operational excellence, or relevant supply chain certification preferred.