Supply Chain Mgr. – Amgen – Municipio de Juncos, Puerto Rico
Under minimal supervision 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.
1. Direct and coordinate daily activities of personnel responsible for material receipt, storage, distribute and transport.
2. Ensures materials are received, stored and transported/shipped according to established performance standards and all applicable procedures and regulations.
3. Interacts with internal and external regulatory agencies to ensure compliance with cGMP, GDP, IATA, DOT, OSHA requirements.
4. Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product.
5. Identify and oversee implementation of new and improved business and compliance systems and tools.
6. Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.
7. Responsible for business continuity programs for assigned areas.
8. Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Amgen Supply Chain.
9. Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts.
10. Organize and communicate on a regular basis the total demand and supply requirements to senior management.
11. Manage the process of gathering, evaluating and feedback of global distribution requirements.
12. Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans.
13. Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
14. 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
15. Generates and approves the assessment reports in EDMQ.
16. Owns and maintains the temperature monitoring plan.
17. Manage transportation carriers
18. Perform transportation investigation, when applicable.
19. Authors, reviews and/or approves documentation with system qualification activities in accordance with Corporate and site procedures
20. Translate transportation regulations and Amgen SOP’s to executable programs
21. Develop SOP and training programs developed according to new transportation regulatory requirements.
** Other functions may be assigned
Basic Education & Experience
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
-While performing the duties of this job, the environment for the staff member is of an office atmosphere. Computer terminals, telephones, and calculators are in use constantly.
-Assignments are received in task and objective oriented terms. Provides direction to subordinates using established policies and procedures. Work is reviewed upon completion for adequacy in meeting the task / objective.
-Administers policies and procedures that typically affect individual staff members within one or more functional work groups.
-Accomplishes tasks mainly through general supervision of nonexempt and experienced exempt employees.
-Monitors daily operations of a work group and actively assists, or provides direction to subordinates. May perform ongoing operational tasks.
-Makes decisions regarding group operations.
-Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources.
-Ensures tasks and projects are efficiently completed on schedule following established procedures and within budget.
-Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher. Regularly conducts briefings to management. Liaison normally involves specific phases of a project or operation. External contacts are regular and generally involve coordinating operational issues.
-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
-Communication and presentation skills (verbal and written)
-Able to work autonomously
-Able to work under pressure
-Understanding of warehouse and distribution business processes
-Validation and Qualification Knowledge
-Project Management Skills