Transportation Specialist – Amgen – Juncos, Puerto Rico
The Transportation Specialist is responsible for maintaining and executing controlled environment logistics and transport validation processes. 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 RESPONSABILITIES INCLUDE BUT ARE NOT LIMITED TO:
Owning and managing NCs, CAPA and site/global Change Controls.
Conducting transport validation assessments for change controls.
Drafting and executing Transport Validation Master Plans, Operational & 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 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.
Manage cold chain supply chain compliance.
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.
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.
Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
Identify and anticipate schedule slips or changes and analyzes the costs, resource and compliance impact.
Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
Identify or lead focus area projects within the overall function of project management or related projects.
Generate periodic updates and prepare formal presentations for required forums.
Generate individual and more complex reports utilizing various resources.
Ensure project work complies with domestic and international regulatory requirements and approved guidelines relevant to area of responsibility.
Ensure project work complies with practices, policies and standard operating procedures.
Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
Anticipate resource needs and communicate to management sponsors.
Responsible for setting up transportation lanes and in conjunction with Quality owns decisions regarding the set up and assessment of transportation lanes originating from the site.
Generates and approves the assessment reports in EDMQ.
Manage transportation carriers.
Perform transportation investigation, when applicable.
Authors, reviews and/or approves documentation with system qualification activities in accordance with Corporate and site procedures.
Translate transportation regulations and Amgen SOP’s to executable programs.
Develop SOP and training programs developed according to new transportation regulatory requirements.
Direct and coordinate daily activities of personnel responsible for material receipt, storage, distribute and transport.
Ensures materials are received, stored and transported/shipped according to established performance standards and all applicable procedures and regulations.
Interacts with internal and external regulatory agencies to ensure compliance with cGMP, GDP, IATA, 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.
Manage the process of gathering, evaluating and feedback of global distribution 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.
Responsible for setting up transportation lanes and in conjunction with Quality owns decisions regarding the set up and assessment of transportation lanes originating from the site.
Authors, reviews and/or approves documentation with system qualification activities in accordance with Corporate and site procedures.
Translate transportation regulations and Amgen SOP’s to executable programs.
Owning and managing NCs, CAPA and global Change Controls.
Drafting and executing transport lane characterization protocols and author reports.
Maintaining lane characterization data repository.
Measuring cold chain 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.
Basic Qualifications:
Doctorate degree
OR
Master’s degree & 3 years of experience in Supply Chain and/or Transportation
OR
Bachelor’s degree & 5 years of experience in Supply Chain and/or Transportation
Preferred Qualifications:
Strong communication and technical writing skills.
Strong ability to work in cross functional teams.
Working knowledge and understanding of GMP regulations and GDP requirements.
4+ years of experience in cold chain logistics, quality, compliance, regulatory affairs, 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.
Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
Skills in working under time pressure, and effectively in a team matrix environment.
Practical project management software and spreadsheet skills, proficient computer operation skills.
Effective interactions in a team or matrixes environment.
Good organizational skills, detail-oriented, accurate & analytical skills.
Team player, self-starter, persistent, tactful, and persuasive.
Effective verbal and written communication skills (writing and presentations).
Ability to assume increasing levels of responsibility.
Motivated self-starter who is able to change in an ambiguous environment.
Fluent English and Spanish (verbal and written).
Good negotiation skills, problem solver and proven ability to deliver results.
GMP, GDP, IATA, DOT and TSA knowledge.
Cold Chain and transportation knowledge.
Experience with audit processes including CAPA.
Experience in managing suppliers and improving processes.
Understanding logistics processes of parcel, transport and warehousing providers.
Strong communication and presentation skills (verbal and written).
Able to work independently, under pressure and in teams.
Understanding of warehouse and distribution business processes.
Technical writing and project management skills.
Validation and Qualification Knowledge.
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.
