Supply Chain Manager-Transportation – Amgen – Juncos, Puerto Rico
Under minimal supervision the Supply Chain Manager provides Supply Chain work group supervision and technical expertise in support of successfully completing daily operations within scope of responsibility. Ensures all work is completed with minimal disruption and in compliance with all cGMP/GDP guidelines and Amgen procedures. 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:
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
Generates and approves the assessment reports in EDMQ.
Owns and maintains the temperature monitoring plan.
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.
Foreign Trade Zone Administrator Role:
Provide technical and administrative support to the Foreign Trade Zone (FTZ) operation to comply with 19 CFR Part 146.
Responsible for the coordination of all FTZ activities in the complex, including but not limited to overall inventory control monitoring, coordination of required compliance programs and activities, Corporate and Site audit plans and related corrective actions.
Record keeping of all FTZ required documentation including Customs CBP Form 214, CBP Form 7501, CBP Form 3461, CBP Form 7512 and CBP Form 216.
Provide support for obtaining applicable shipment permits for the movement of FTZ Materials.
Prepare and send the Weekly Reconciliation Report and the Weekly Estimate Report.
Prepare and send the FTZ Annual Reconciliation Report to the FTZ Board of the International Trade Administration.
Maintain and update FTZ SOP and FTZ Operation Manual according Customs regulations.
Create relationship with industry peers for benchmarking and to share best practices for the FTZ operations and related issues.
Manage Customs and Border Protection audits.
Doctorate degree in Life Sciences and/or Business Administration
Master’s degree in Life Sciences, Business Administration, Finance and/or Engineering and 3 years of experience in Business Planning, Manufacturing or Supply Chain Functional Operations
Bachelor’s degree in Life Sciences, Business Administration, Finance and/or Engineering and 5 years of experience in Business Planning, Manufacturing or Supply Chain Functional Operations
Facilitation and presentation skills
Strong analytical problem solving skills
Strong technical writing skills
Strong project management skills
Change management skills
Ability to influence staff and effect change outside of area of responsibility
Initiate and lead cross-functional teams to resolve complex issues
Good decision making skills
Technical expert for function
Possess an understanding and appreciation of the Amgen Values and Leadership Attributes
Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
Skills in working under time pressure, and effectively in a team matrix environment.
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
Proven ability to deliver results
GMP, GDP, IATA, DOT and TSA knowledge
Cold Chain and transportation knowledge
Experience with audit processes including CAPA, etc.
Experience in managing suppliers and improving processes
Understanding logistics processes of parcel, transport and warehousing providers
Able to work autonomously
Able to work under pressure
Understanding of warehouse and distribution business processes
Validation and Qualification Knowledge
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.