Supply Chain Manager

• Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Amgen procedures.
• Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport.
• Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations.
• Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements.
• Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product.
• Identify and oversee implementation of new and improved business and compliance systems and tools.
• Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.
• Responsible for business continuity programs for assigned areas.
• Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Amgen Supply Chain.
• Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts.
• Organize and communicate on a regular basis the total demand and supply requirements to senior management.
• Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan.
• Manage the process of gathering, evaluating and feedback of global demand requirements.
• Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans.
• Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
• Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.

• Ph.D OR MS + 2 years of directly related experience OR BS + 4 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience.

• Educational background in Life Science and/or Engineering
• Written and Verbal communication in English and Spanish
• In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why’s)
• Supply Chain experience (receiving, suppliers, warehouse, shipping)
• Strong Technical Writing Skills
• Skilled in performance of GMP operations
• Compliance/Regulatory knowledge and interaction experience
• Experience leading cross-functional teams for RCA and problem solving
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, supply chain, and quality.
• Strong presentation skills.
• Project management skills.

• Complete Root Cause Analysis
• Apply Process Expertise – capable of understanding process and controls require to assess for potential causal factors
• Assess process performance by observation of floor operations and review of performance data.
• Support trouble shooting to identify Causal Factors and potential corrections
• Evaluate operational procedures
• Evaluate training requirements for technical aspects of the process
• Identify training opportunities
• Use and perform Risk Assessments as required to identify and understand risks and failure modes
• Define CAPAs
• Evaluate process improvement opportunities
• Negotiate Actions with Partners
• Deliver timely robust plan to address Root Cause
• Perform Impact to Process /Equipment /System Assessment
• Team with Product Development to understand potential impact to product quality attributes
• Assess Equipment/Systems information for potential impact to product quality attributes
• Assess for Data Integrity
• Assess for Process Validation Impact
• Author Investigation Report
• Use Technical Writing techniques proficiently
• Perform Data Verification
• Ensure timely report approval
• Support Peer Review
• Follow current standard procedures/templates
• Serve as SME to define deviation designation when called upon
• Facilitate Process and Equipment Risk Assessments and make recommendations to mitigate risks
• Participate in regulatory inspections
• Participate in the assessment or implementation of special projects or initiatives.
• Make strategic planning to support product supply and business performance metrics.

Mentor Technical Group