Sr Associate Clinical Finish Drug Product Global Study Planner Support

Amgen Inc. (IR); Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Clinical Supply Chain professional to ensure continuous product supply for patients in global clinical trials.

The role interfaces with Global Study Planners and internal/external customers to execute planning, labeling, stock transfers, and destruction activities in ERP, while upholding GMP/GDP standards. You will manage workload, participate in risk mitigation, and drive continuous improvement initiatives across teams to align with global priorities and regulatory

Qualifications

• Bachelor’s Degree and 5+ years of supply chain, logistics, planning, or operations experience.
• Master’s Degree and 5+ years of relevant experience.
• Experience with document workflows in Veeva Vault and regulated manufacturing are a plus.

Responsibilities

• Accurate and timely execution of clinical supply chain activities.
• Execute production order conversion, stock transfer orders, and planning cycles.
• Provide SME input to peers on complex operational processes.
• Support global study planners across time zones and partners.
• Maintain compliance with GMP/GDP and regulatory requirements.

Skills

Problem solving

Analytical skills

Organizational skills

Communication (English)

Cross-functional teamwork

Stakeholder management

Adaptability

Education

Bachelor’s Degree

Master’s Degree

Tools

SAP ERP

Job description

Career Category Supply Chain Job Description Role Description Let’s do this. Let’s change the world. In this vital role, you will serve as lynchpin between Global Study Planners and internal and external customers to ensure supply for our important patients participating in Amgen’s global clinical trials. Along with local team members, you support the execution of clinical planning processes and ensure the execution of activities so that Finished Drug Product is available from study start throughout study closure. You closely interact with Global Study Planners in Europe and USA. Reporting to the Manager Clinical Finish Drug Product and Comparator Supply, you support the global execution of clinical planning processes. While the Global Study Planner decides the need for sufficient inventory and timely destruction, you execute on these requests. Each day you handle the requests for new labeling jobs in ERP based on the system signals. Another task is to initiate and follow up stock transfer orders in ERP in close conjunction with the planner’s information for quantity, timing and destination. You initiate the destruction of finish drug product and follow up in case of delays or discrepancies. You are also responsible for several periodic checks and give input to KPI’s. You route controlled documents and update text after review workflow in conjunction with the subject matter expert. The role is accountable for executing complex supply chain processes, accurate, timely and GMP compliant execution and follow up. You provide operational oversight across supply planning, order management, material destruction and indicate problems and inconsistencies. In close collaboration with your local peers, you give support to the Global Study Planners based in other parts of the world. You manage workload prioritization and participate in performance management, risk mitigation, and continuous improvement initiatives across the teams, ensuring alignment with the global clinical supply chain priorities, regulatory requirements, and financial objectives.

Roles & Responsibilities

• Accurate and timely execution
• Execute under clear priorities
• Support rushes as needed
• Participate in issue triage, corrective actions, and workload prioritization with global peers.
• Ensure timely escalation and resolution of planning, procurement, and execution risk.

Clinical Supply Chain Execution

• Execute production order conversion, stock transfer order initiation, and clinical planning cycle facilitation to ensure product supply plans are executed against appropriately
• Execute in study close out activities including material destruction.
• Provide Subject Matter Expertise to peers on complex operational processes.

Performance & Process Management

• Update procedures to keep them current, compliant and inspection ready.
• Provide input to team KPIs related to service level, execution timelines, and right first-time delivery.
• Drive root cause analysis and continuous improvement to address gaps and enhance team outcomes.
• Adopt new technologies and AI to increase team productivity performance.
• Represent the team during audits and inspections.

Cross-Functional & Global Collaboration

• Partner with planners, internal and external labeling facilities, Amgen warehouses, Logistic Service Providers and Quality.
• Work with local peers to prioritize the work to avoid a back log.

Compliance & Accurate Hand off

• Work Right First Time to all applicable GMP/GDP and Regulatory requirements and Amgen procedures.
• Report risks, inconsistencies and errors.

Functional Skills Must-Have Skills

• Demonstrated accurate and efficient handling of process execution in a complex environment
• Strong problem solving and analytical skills towards driving robust decision making
• Good organizational and communication skills including fluency in English both in oral and written communication with the ability to clearly document and communicate relevant information.
• Demonstrated ability to manage assigned tasks and priorities while meeting deadlines.
• Ability to adapt to evolving priorities that clinical studies that are agile by nature.
• Hands-on knowledge of SAP or similar ERP system for material planning and management.
• Ability to work effectively within cross-functional teams in a regulated or structured environment.
• Collaborative team player with the ability to support shared objectives.
• Experience or exposure to working with stakeholders in other time zones.
• Basic understanding of performance metrics, reporting tools, or data tracking processes.

Basic Qualifications

• Bachelor’s Degree and 5+ years of supply chain, logistics, planning, or operations experience
• Master’s Degree and 5+ years of relevant experience

Preferred qualifications

• Experience with document workflows in Veeva Vault.
• Experience in regulated manufacturing or life sciences industry.
• Exposure to change initiatives, system implementations, or continuous improvement efforts.
• APICS or Lean/Six Sigma certification.

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