Transportation Specialist – Amgen – Municipio de Juncos, Puerto Rico
The majority of Amgen raw materials and products have temperature control requirements which must follow stringent GMP and GDP regulations. This position is key for requirement and regulation adherence. The position 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 validation activities to support product commercialization.
SPECIFIC RESPOSABILITIES INCLUDE BUT ARE NOT LIMITED TO:
Maintaining and executing controlled environment logistics and transport validation processes by:
- Owning and managing NCs, CAPA and global Change Controls.
- Conducting transport validation assessments for change controls.
- Drafting and executing Transport Validation Master Plans, Operational Qualifications and Performance.
- Qualifications protocols and author reports to meet product commercialization milestones, 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 best practices 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 driving 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 Latin America alignment towards: Global Lean Warehouse, Distribution and Transport Standards; Global Import/Export Compliance; Controlled Environment Logistics. Leverage industry partnerships to implement best practice.
Master’s degree & 3 years of Supply Chain experience
Bachelor’s degree & 5 years of Supply Chain experience
- Strong communication and technical writing skills.
- Strong ability to work in cross functional teams.
- Working knowledge and understanding of GMP regulations and GDP requirement.
- 4+ 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.
- Bilingual (Spanish and English)
- Willing to Travel 10%-30%.