Transportation Specialist

Are you looking for a meaningful new opportunity to test and growth your logistics skills? We have an immediate need for a Transportation Specialist to join AML's Supply Chain Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

This position is key for requirement and regulation adherence and is responsible for maintaining and managing the controlled environment logistics and transport validation processes. Effective management and execution will ensure reliable delivery of raw materials, bulk and finished products as well as successful transport qualification activities to support product commercialization.

The Department

Global Supply Hub (GSH) is an organization within Global Supply Chain that strive for reliable and efficient supply of final drug products to the market and intermediates within Amgen network.

The core business of GSH are:

• Transportation
• Cold Chain compliance
• Product security
• In the market product supply
• Order Management (import / export)
• Global Trade Operations

GSH is a cornerstone for Amgen continues growth in International footprint while establishing a center of excellence for global supply opportunities.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Maintaining and executing controlled environment logistics and transport validation processes
• Owning and managing NCs, CAPA and global Change Controls.
• Conducting transport validation qualification assessments for change controls.
• Drafting and executing Transport validation qualification Master Plans, Operational Qualifications and Performance.
• Qualifications protocols and author reports to meet product commercialization achievements, including regulatory filings deadlines.
• Coordinating and participating in risk assessments and author summary reports.
• Drafting and executing transport lane characterization protocols and author reports. Maintaining lane characterization data repository.
• Measuring cold chain compliance, process metrics and key performance indicators. Partnering with network members and key functional areas to problem solve and implement global cold chain solutions to reliably deliver materials and products to global supply chain points.
• Implementing and executing current good shipping/distribution practices to ensure compliant transport process.
• Continuously improving transport process procedures to maintain compliance and effectively support product transfer and commercialization.
• Continuously growing knowledge of industry practices.
• Implement distribution projects that support the region's strategic plans.
• Work cross functionally by establishing new supply routes, supply sites, distribution models.
• Build financial justification distribution models.
• Serve as Distribution Subject Matter Expert for audit of third party distribution partners (Logistics Service Providers, carriers and distributors).
• Partner with Global Logistics to share standard methodologies and gain alignment.
• Conduct monthly report on Transportation performance and drive improvements.
• Partner with International Commercial Operations and Global Logistics to develop and assess optimal Latin America strategy.
• Manage third party distribution partners (LSP, carriers and distributors) to meet Service Level agreements.
• Use Operational Excellence as an approach to drive continuous improvement in performance and cost reduction distribution strategies.
• Ensure compliance with Regional import /export requirements. Accountable for implementation of key Regional Commercial Distribution initiatives.
• Accountable for Supply Hub alignment towards: Global Lean Warehouse, Distribution and Transport Standards; Global Import/Export Compliance; Controlled Environment Logistics. Demonstrate industry partnerships to implement standard methodology.

Basic education & experience

Doctorate degree

OR

Master's degree & 2 years of Supply Chain or GMP/GDP Pharmaceutical Industry experience

OR

Bachelor's degree & 4 years of Supply Chain or GMP/GDP Pharmaceutical Industry experience

Beyond that, additional preferred qualifications are:

• Educational background in Business Administration, Science or Engineering
• Strong communication and technical writing skills.
• Excel and PowerPoint Microsoft Office proficiency.
• Strong ability to work in cross functional teams.
• Working knowledge and understanding of GMP regulations and GDP requirement.
• 1+ more years of experience in Cold Chain Logistics, Quality, Compliance, Regulatory Affairs and/or Supply Chain.
• Operational Excellence experience or training.
• Distribution and Transportation knowledge of Latin American Import & export Regulations for Biotech products.
• Biotech cold chain distribution compliance across Latin America countries.
• Understanding of Latin America countries infrastructure capabilities to development distribution network for biotech products introduction.
• Previous interactions with Customs Authorities and Freight Forwarder associations.
• Experience with local cross functional working groups for developing policies and guidelines across the region.
• Fully Bilingual (Spanish and English)
• Willing to Travel 10%-30%.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.