13 days old

Senior Associate Regional Operations

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119119221
Amgen

Job ID: R-94316
Location: Thousand Oaks, CA, US 91360

The Supply Chain Senior Associate is a key position for Intercontinental, Latin America (ICON-LATAM) Region's commercialization strategy, product launch & life-cycle management and Strategy development plan. The Supply Chain Senior Associate role will include cross functional collaboration to ensure successful launches, establish new supply routes, provide input to establish supply sites, determine distribution models, setting up systems, managing variations by figuring out strategy and overall launch coordination.

Specific responsibilities include but are not limited to:
  • Serve as Operations champion for ICON's commercialization strategy for assigned product(s) and projects
  • Lead Regional Operations Team Meetings to handle launch and product life-cycle events
  • Develop launch plan including deliverables and timelines
  • Lead cross functional meetings and ensure plans are in place, valid and clearly communicated
  • Represent the Region and Operations for assigned region-product(s) at Product Delivery Teams (PDT) and other global, regional, site and/or country meetings as needed to ensure strategy at corporate levels is developed taking into consideration the regionals and country requirements
  • Regularly and clearly communicate region's decision, risks, and project timeline to the PDT and appropriate Operations management and governance forums
  • Generate project charters and ensure project gate reviews are in alignment with international commercialization process; manage within regional budget requirements
  • Participate in Operational Excellence opportunities and drive regional improvements and cost savings by using Network Knowledge sharing forums
  • Develop regional network supply strategy with Global Supply Chain and Sites
  • Ensures un-disrupted patient supply by performing supply risk assessment and developing mitigation plans during the management of product life-cycle events
  • Participate at Demand and Supply Alignment/Hand-off and S&OP meetings for assigned product/market
  • Represent the supply network and work with region's cross functional team (commercial, finance, regulatory affairs, quality) to develop compliant product supply strategy for the planning horizon
  • Represent the region commercial needs and work with supply network to resolve supply conflicts
  • Own cross functional alignment throughout the commercialization for the product(s), end to end
  • setup of Physical and Financial Flows specific for product and country
  • Execute Operations Commercialization Strategy through regional strategy development and management
  • Lead all aspects of product launch change control records with SCPM hub, owns change control records as necessary
  • Partner with regional planner to ensure timely setup of SKU and system readiness
  • Contribute to preparation and review of supply agreements and regulatory documentation
  • Lead Regional variation management review process to resolve supply strategy for assigned products
  • Primary accountable to ensure variations implementation occurs as per regulatory and corporate requirement and ensure product supplied aligns with the country's requirements
  • Ensure country regulations and requirements are clearly understood and incorporated into the global and regional processes
  • Ensure compliant execution to meet local regulatory, trade, and quality regulations
  • Ensure adherence to Service Level Agreements (SLA) with manufacturing sites


Basic Qualifications:

Master's degree

Or

Bachelor's degree and 2 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience

Or

Associates degree and 6 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience

Or

High school diploma / GED and 8 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience

Preferred Qualifications:
  • Bachelor/Master's Degree in Business, Supply Chain, Operations
  • Proficient in English and Spanish, oral and written (Portuguese a plus)
  • APICS or Supply Chain equivalent certification
  • 2 years of experience in Pharmaceutical product commercialization, Life Cycle Management, Product Launches, Planning, Regulatory Affairs, Clinical Development and/or International Supply Chain operations
  • Understanding of marketing principles and competitor practices
  • Experience in project management across departments
  • Experience working with multiple geographies and cultural backgrounds worldwide
  • Ability to recognize strategic implications of complex product development activities and handle them cross-functionally
  • Strong analytical skills and ability to summarize and communicate findings
  • Independent self-starter, able to work autonomously, under pressure and in teams under minimum supervision
  • Problem solver with high sense of responsibility to achieve results
  • Strong communication and presentation skills (verbal & written).
  • GMP knowledge and understanding of pharmaceutical regulations
  • Understanding of Quality and regulatory requirements


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI119119221

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94316<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Supply Chain Senior Associate is a key position for Intercontinental, Latin America (ICON-LATAM) Region's commercialization strategy, product launch & life-cycle management and Strategy development plan. The Supply Chain Senior Associate role will include cross functional collaboration to ensure successful launches, establish new supply routes, provide input to establish supply sites, determine distribution models, setting up systems, managing variations by figuring out strategy and overall launch coordination.<br><br>Specific responsibilities include but are not limited to:<br><ul><li>Serve as Operations champion for ICON's commercialization strategy for assigned product(s) and projects</li><li>Lead Regional Operations Team Meetings to handle launch and product life-cycle events</li><li>Develop launch plan including deliverables and timelines</li><li>Lead cross functional meetings and ensure plans are in place, valid and clearly communicated</li><li>Represent the Region and Operations for assigned region-product(s) at Product Delivery Teams (PDT) and other global, regional, site and/or country meetings as needed to ensure strategy at corporate levels is developed taking into consideration the regionals and country requirements</li><li>Regularly and clearly communicate region's decision, risks, and project timeline to the PDT and appropriate Operations management and governance forums</li><li>Generate project charters and ensure project gate reviews are in alignment with international commercialization process; manage within regional budget requirements</li><li>Participate in Operational Excellence opportunities and drive regional improvements and cost savings by using Network Knowledge sharing forums</li><li>Develop regional network supply strategy with Global Supply Chain and Sites</li><li>Ensures un-disrupted patient supply by performing supply risk assessment and developing mitigation plans during the management of product life-cycle events</li><li>Participate at Demand and Supply Alignment/Hand-off and S&OP meetings for assigned product/market</li><li>Represent the supply network and work with region's cross functional team (commercial, finance, regulatory affairs, quality) to develop compliant product supply strategy for the planning horizon</li><li>Represent the region commercial needs and work with supply network to resolve supply conflicts</li><li>Own cross functional alignment throughout the commercialization for the product(s), end to end</li><li>setup of Physical and Financial Flows specific for product and country</li><li>Execute Operations Commercialization Strategy through regional strategy development and management</li><li>Lead all aspects of product launch change control records with SCPM hub, owns change control records as necessary</li><li>Partner with regional planner to ensure timely setup of SKU and system readiness</li><li>Contribute to preparation and review of supply agreements and regulatory documentation</li><li>Lead Regional variation management review process to resolve supply strategy for assigned products</li><li>Primary accountable to ensure variations implementation occurs as per regulatory and corporate requirement and ensure product supplied aligns with the country's requirements</li><li>Ensure country regulations and requirements are clearly understood and incorporated into the global and regional processes</li><li>Ensure compliant execution to meet local regulatory, trade, and quality regulations</li><li>Ensure adherence to Service Level Agreements (SLA) with manufacturing sites</li></ul><br><br><b>Basic Qualifications:</b><br><br>Master's degree<br><br>Or<br><br>Bachelor's degree and 2 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience<br><br>Or<br><br>Associates degree and 6 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience<br><br>Or<br><br>High school diploma / GED and 8 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience<br><br><b>Preferred Qualifications:</b><br><ul><li>Bachelor/Master's Degree in Business, Supply Chain, Operations</li><li>Proficient in English and Spanish, oral and written (Portuguese a plus)</li><li>APICS or Supply Chain equivalent certification</li><li>2 years of experience in Pharmaceutical product commercialization, Life Cycle Management, Product Launches, Planning, Regulatory Affairs, Clinical Development and/or International Supply Chain operations</li><li>Understanding of marketing principles and competitor practices</li><li>Experience in project management across departments</li><li>Experience working with multiple geographies and cultural backgrounds worldwide</li><li>Ability to recognize strategic implications of complex product development activities and handle them cross-functionally</li><li>Strong analytical skills and ability to summarize and communicate findings</li><li>Independent self-starter, able to work autonomously, under pressure and in teams under minimum supervision</li><li>Problem solver with high sense of responsibility to achieve results</li><li>Strong communication and presentation skills (verbal & written).</li><li>GMP knowledge and understanding of pharmaceutical regulations</li><li>Understanding of Quality and regulatory requirements</li></ul><br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/DowqywIm5YKgsYwysqmY6"> <p>PI119119221</p>

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Posted: 2020-03-18 Expires: 2020-04-18

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Senior Associate Regional Operations

Amgen
Thousand Oaks, CA 91360

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