Amgen Regional Operations Mgr in Thousand Oaks, California

As Amgen expands globally, is a key position in implementing the Intercontinental-Latin-America (ICON-LATAM) Region's commercial strategy, product launch & lifecycle plans. The Regional Operations Manager role will include cross functional collaboration to establish new supply routes, supply sites, distribution models, setting up systems, managing variations, and overall launch coordination.

SPECIFIC RESPOSIBILITIES 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 manage launch and product lifecycle events

  • Lead cross functional meetings and ensure plans are in place, valid and clearly communicated

  • Represent Operations for assigned region-products) at Product Delivery Teams (PDT) and other global, regional, site and/or country meetings as needed

  • Regularly and clearly communicate region's decision, risks, and project timeline to the PDT and appropriate Operations management/governance

  • 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 leveraging Network Knowledge sharing forums

  • Develop regional network supply strategy with Global Supply Chain and Sites

  • Ensures undisrupted patient supply, supply risk assessment and mitigation plans during the management of product lifecycle 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 and setup of Physical and Financial Flows specific for product and country

  • Execute Operations Commercialization Strategy through regional strategy development and management; ensure regional adherence to CMC Excellence

  • Oversee product launch change control records with SCPM hub, owns change control records as necessary

  • Owns ERP systems setup (such as the creation of sales org, material # and customer #); partner with regional planner to ensure timely setup

  • Contribute to preparation and review of supply agreements and regulatory documentation

  • Lead Regional variation management review process to determine supply strategy for assigned products

  • Ensure country regulations and requirements are clear and incorporated into the global process

  • Ensure compliant execution to meet local regulatory, trade, and quality regulations

  • Ensure compliance to Service Level Agreements (SLA) with manufacturing sites

BASIC QUALIFICATIONS:

Doctorate degree

Or

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

Or

Bachelor's degree and 4 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience

Or

Associate's degree and 10 years of Supply Chain / Customer Service experience in a GMP and/or Good Distribution Practice regulated industry experience

OR

High school diploma / GED and 12 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, or Engineering

  • APICS or equivalent certification

  • 3 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 and geographies

  • Ability to recognize strategic implications of complex product development activities and manage them cross-functionally

  • Quick process understanding, insight and visualizing

  • Fluent in English oral and written; Proficiency in Spanish language (Portuguese a plus)

  • Strong analytical skills (incl. MS Excel, MS Power Point) and ability to summarize findings

  • Independent self-starter, able to work autonomously, under pressure and in teams

  • Problem solver with high sense of responsibility to achieve results

  • Strong communication and presentation skills (verbal & written)

  • GMP knowledge and understanding of pharmaceutical regulations

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 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.

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.

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.