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Associate Director, Materials Management - United States
Kite Pharma (company)
Posted on : 26 February 2017
- Our company is an innovative, rapidly growing company located in beautiful CA dedicated to the development and commercialization of new cancer immunotherapies with exciting early trial results.
- These therapies harness the power of a patient’s own immune system to fight tumor cells.
- We are on a rapid growth trajectory and have a highly energized and accomplished team.
- Our company is publicly traded with a current market well over $2 Billion.
- We are seeking a highly motivated individual for the role of Associate Director, Materials Management to work in this exciting new area of cancer immunotherapy to develop, manage and maintain a GMP/Non-GMP warehouse and inventory management system.
- Materials Management falls within the Manufacturing Operations Department.
- The Materials Management Department effectively and efficiently supports corporate manufacturing and quality goals to ensure manufacturing operations are met. The Materials Manager will report to the Vice President of Operations.
- In this role you will assist in managing and training materials management personnel to support manufacturing operations, product shipping, and component receiving to ensure inventory accuracy and timely supply of materials to manufacturing production rooms to meet demands.
Responsibilities (include but are not limited to):
- Manage operational GMP and Non-GMP clinical stage warehouse facility
- Manage inventory management system conforming to standard warehouse practice (Bar Code, FIFO, re-order triggers, etc.)
- Completes daily inventory transactions including inventory transfers, inventory adjustments and disposals in the inventory database
- Manage pick and pack system for supply kits to manufacturing groups utilizing a Bill of Material
- Manage receiving system for both products and materials
- Manage packaging and shipment of final product
- Monitor commercial/clinical inventory report for quantity, lot status, expiration dates
- Rebalances inventories based on lot expiration and QA requirements, as needed
- Manage disposition of GMP Raw materials
- Understands and implements safety procedures and GMP’s
- Create and/or updates area standard operating procedures (SOP’s) as required
- Develop and implement protocols and practices to ensure effectiveness and efficiency of strategic initiatives and inventory/warehouse management
- Develop inventory strategies that minimize financial impact and develops systems to manage materials across multiple clinical studies
- Participate in the development, revision and accuracy of production plans
- Investigates and resolves inventory discrepancies in a timely manner
- Overseeing, either directly or indirectly, Manufacturing investigations, process variances and deviations
- Experience with working on the implementation, process mapping and creation of Materials Management modules, and User Acceptance Testing (UAT) for ERP systems as it relates to receipt, inspection, disposition, inventory, kitting, and shipping of GMP Materials
- Lead strategic planning of Materials Management projects, including implementation of a new Enterprise Resource Planning System (e.g., EBS Oracle).
- Undertaking long and short-term planning and supervision of projects that require interaction with Manufacturing.
- Hire, train, develop, direct, mentor, and evaluate team members to accomplish established goals. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with the VP of Manufacturing and Human Resources as appropriate.
- Managing employees, either directly or indirectly, who are involved in the scheduling, implementation, execution and/or maintenance of manufacturing processes and operations
- Provide work direction and coordinate of the schedules and activities of assigned personnel; assist in training materials management personnel in area SOP’s and compliance
- Plan, oversee and participate in the materials management operations and activities to support materials team and internal customers
- Manage the day-to-day assignment of materials management tasks and monitor completion of required activities
- Assist the head of the department in managing the budget and ensure department adhere to the approved budget
- Apply new warehouse technologies to minimize errors, and improve efficiency
- Knowledge of lean process and implementation (5S, Six Sigma)
- Drive continuous improvement of the supplies movement, warehouse level optimization, kitting and Kanban processes
- Experience leading and preparing department for Regulatory Agency Inspection
- Other duties as assigned
Leadership Responsibilities Include:
- Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
- Establishing departmental and individual goals and objectives in alignment with site goals and priorities. Identifying performance improvement targets and metrics. Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets.
- Providing effective leadership including: developing and implementing objectives and business strategies; challenging employees to develop as leaders while serving as a role model and mentor; assisting with performance calibration/talent pool management/succession planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in the management of their employees/department which support achievement of individual/department/business objectives
- Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
- Motivating, retaining and developing employees. Building and sustaining employee engagement by creating an environment within which individuals and teams can excel.
- Strengthening overall leadership and organizational capabilities in area of responsibility. Building and sustaining high performance management team and ensuring strong alignment and coordination with other functional groups at the site.
- Identifying and communicating risks in area of responsibility and across the site; creating strategies and plans to manage risk to the operations.
- Participating in development of site long range in line with the corporate long range planning.
- Managing headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.
- Bachelor’s degree in supply chain or related discipline or equivalent qualification in business administration
- At least 15 years of relevant supply chain, warehouse/distribution operations at a pharmaceutical or biotech company
- Other continuing education certifications highly desirable (e.g. Six Sigma, 5S, 6S, industry specific coursework)
- Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines
- In depth knowledge of warehouse operations in a GMP/non-GMP setting
- Demonstrated technical skills in Materials Management
- Strong management skills and experience in commercial/clinical bio-pharm or medical supplies management with the flexibility to handle multiple tasks
- Strong knowledge and understanding of pharmaceutical or medical Supply Chains. International distribution experience
- Working knowledge of Commercial and Clinical Trial Materials development, manufacturing, packaging and labeling
- Cold chain knowledge and experience in a pharmaceutical or medical setting
- Experience with Oracle Fusion, SAP and similar strongly preferred
- Previous experience in Materials Management, Logistics, Distribution and Supply Chain preferred
- Leadership skills that motivate and energize a group or an individual for peak performance.
- Process-oriented with strong analytical skills for risk identification and management
- Excellent verbal and written communication skills and can confidently communicate with all levels of staff in this collaborative work environment.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Experience preparing and leading Regulatory Agency Inspections
- Proficient in MS word, Excel, PowerPoint, Outlook and Warehousing software