Supply Chain Senior Associate

Summary

Support the Amgen KK Supply Chain by ensuring continuous supply and delivering to customers/patients on time, in full, cost effectively and in compliance with local regulations and laws.Reporting to the Japan Market SCM Sr Manager, the key areas of responsibility include the support of country-level launch readiness and lifecycle management for assigned products under Sr manager / Manager of commercial supply chain, including the coordination and execution of product launches and execution of variations in commercial products. Also provide support for Customer service and Logistics operations. (following GMP, GDP, GQP, SOX and company specific requirements.)

Specific Responsibilities

• Accountable for supporting Japan launches/lifecycle management for assigned products within the Japan portfolio under Sr Manager/Manager of commercial supply chain:
  • Serve as an Operations Supervisor under Sr Manager/Manager of commercial supply chain for Japan commercialization within local product teams as well as regional/global forums.
  • Support leading the Japan Product Delivery Team (JPDT), which is made up of SCM, QA and CMC team members.
  • Contribute to the Japan product strategy and launch planning by managing Operations risks, decisions, timelines, and tasks, and communicating to appropriate teams and governance bodies.
  • Ensure adherence to regional/global CMC and commercialization processes and gates, such as Commit-to-File, Commit-to-Launch and Commercialization Readiness/Market Launch.
  • Support cross-functional and cross-site teams and meetings in the development and execution of local Operations launch readiness and product lifecycle/variation management activities under Sr Manager/Manager of JP market supply chain.
• Collaborate within Supply Chain and across various functional teams (commercial, regulatory, quality, finance) at the local/regional/global levels to develop and implement a compliant and robust supply strategy.
  • Proactively identify risks, develop mitigation plans and engage key stakeholders to ensure continuous patient supply.
  • Support Japan commercial, regulatory and quality requirements to Global Supply Chain and Amgen manufacturing sites as COL under Sr Manager/Manager of JP commercial supply chain.
  • Support global Operations network during local demand/supply planning discussions (e.g., S&OP, IBP) as COL under Sr Manager/Manager of JP commercial supply chain.
  • Support Amgen’s priorities and expectations for supply plan along with CMO Site Manager as COL under Sr Manager/Manager of JP commercial supply chain...
• Manage and support change control management process for commercial distribution readiness related to product launches, CMC variations and labeling changes, in partnership with Regional Operations Leads; key tasks may include as COL under Sr Manager/Manager of JP commercial supply chain.
  • Ensure timely set-up of critical systems and master data in conjunction with Japan demand planner.
  • Prepare, review and approve CMO-related documentation for product launch/variations in conjunction with CMO Site Manager.
• Provide support for other quality system processes, such as initiation/completion of deviations at local level.
• Provide processing and support for the system processes operation (SAP, Ariba and others) , such as issue Inventory, Receiving and status changes (+ others) for customer service and Logistics related at local level.
• General Responsibilities
  • Ensure local regulatory, trade and quality compliance requirements are met.
  • Identify opportunities to improve through our Drive for Excellence program. and execute. Support change, innovation, operational excellence and solve problems.
  • Provide monthly updates and report country-level KPIs to key stakeholders.

Basic Education & Experience

• Bachelor’s Degree in business administration, supply chain, science-related field or similar.
• 5+ years of experience in Supply chain, Manufacturing, Quality or CMC-related function within the pharmaceutical industry, preferably in biotechnology.
• 2+ years in roles requiring knowledge of pharmaceutical product commercialization, launch readiness, and lifecycle management.
• Experience in working at a multi-national/global company with diverse cultures.
• Capability for business level English/Japanese communication (E-mail, call and meeting)

Basic Knowledge & Skills

• High degree of language proficiency in both English and Japanese; strong verbal, written, listening and presentation skills
• Good project management skills across functions and preferably across geographies, with past success in participating in high-performing teams and/or influencing others to drive results.
• Good analytical and problem-solving capabilities; uses data analysis tools / methodologies and applies independent judgement to solve problems.
• Ability to recognize the strategic importance of complex product commercialization activities.
• Ability to work in complex operating models and, and strong collaboration skills.
• Ability to work independently by effectively working well with others; taking initiative and remaining adaptable.
• High personal integrity and accountability; drives for excellence, agility, innovation, and efficiency.
• Self-motivated, positively contributes to the work environment by embracing/championing change.
• Result-focused with proven ability to delivery results.
• Basic understanding of supply chain operations and GMP/GDP regulations.
• Consistently demonstrates Amgen Values.

Travel: 10%