Sr Associate Clinical Supply Chain Support Office

Amgen Inc. (IR); Hyderabad; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Amgen Inc. (IR) in Hyderabad, India, invites a Sr Associate to join the Clinical Supply Chain, supporting design and setup of global supply chains for clinical trials. You will lead data gathering across R&D, Regulatory Affairs, Site Supply Chain and Master data, ensuring compliant, right-first-time execution and proactive risk mitigation.

Strong SAP master data and BOM skills are essential. This role emphasizes coordination of artwork requests, product specification files, and depot plans, with

Qualifications

• Bachelor degree or equivalent in logistics, business administration or life science.
• Experience in international and regulated environments.
• Strong MS Office skills (Word, Excel).
• Fluency in English (oral and written).

Responsibilities

• Manage master data requests, BOM and study attributes in SAP.
• Coordinate study design tables setup and ERP readiness.
• Maintain product specification files and depot plans.
• Generate and track metrics for the global setup team.

Skills

Logistics fundamentals

Planning

Project management

English communication

Prioritization & escalation

Education

Bachelor degree or equivalent in logistics, business administration or life science

Tools

MS Office (Word, Excel)

SAP

Job description

Career Category Supply Chain Job Description

In this vital role, you will serve as Sr Associate, supporting the Design and Setup of the Clinical Supply Chain. Reporting to the Manager Clinical Supply Chain-Change Mgt, and directed by the Global Setup Leads, you will contribute to the execution and completion of key deliverables associated with setup activities of global supply chains for clinical trials, by leading information gathering across stakeholders such as R&D, Regulatory Affairs, Site Supply Chain and Master data, and task close out. In close collaboration with the Global Setup Lead team, you will ensure reliable, compliant, and right-first-time process execution, transparent status reporting on progress, and pro-active identification of risks and mitigation strategies for closing out deliverables. The role is accountable for managing various deliverables such as: Master data requests for product materials, Bill of Materials (BOM), and study related attributes in SAP. Creation of the Clinical Artwork requests and facilitating prioritization of outstanding attributes in relation to the request form. Creation and maintenance of Product Specification Files, and Depot Plans.

Roles & Responsibilities

Master Data in ERP (SAP) Central focus point for ERP (SAP) readiness: Initiate clinical label material requests; Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures timely availability to adhere to overall project timelines Ensures setup of Study Design Tables. Setup Activities Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries. Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial Creates and maintains third party depot plans and cross docks to support global study footprint Reporting Maintains Metrics for Global Setup lead team Contributes to monthly Workforce planning cycle

Qualifications

5+ Years of experience with Bachelors Bachelor degree or equivalent in logistics, business administration or life science. Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry, Typically relevant working experience in an international and regulated environment Understanding of fundamentals of logistics/supply chain principles (especially BOM) Experience in planning Experience in project management techniques Advanced experience in MS Office applications (Word, Excel) Fluency in English, both in oral and written communication High quality standards with regards to work Ability to set priorities and timely escalation

Preferred requirements

Knowledge of clinical supply chain management General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, International Conference on Harmonization (ICH) guidelines, Clinical Trial Directive) Experience in using SAP Excellent communicating and facilitating issue resolution skills .

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen