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Associate Director Drug Supply (CAR-T Warehouse Operations)


Security Operations


East Hanover, New Jersey, United States

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>The Associate Director Drug Supply is accountable for Raw Material Planning, Purchasing, Clinical Warehouse Operations, Compliance, Budget, and Staffing. Major responsibilities include overseeing and leading materials management and cGMP Warehouse Operations, such as material planning, purchasing, receiving, storage and distribution of incoming materials (including Leukapheresis), inventory control, and shipping of final product at/from the East Hanover Cell and Gene Therapy Pilot Plant. Other duties include ensuring Compliance for the Materials Management and Warehouse Operations in accordance with Novartis Quality Standards, Regulatory, and local and State governmental requirements. <br><br>Your responsibilities will include, but are not limited to:<br><br>• Accountable for planning and purchasing of raw materials. <br> o Interface with Manufacturing, Quality, and Clinical teams to develop robust materials management and clinical supply chain planning.<br> o Prepare and monitor raw material forecast based on clinical demand and manufacturing schedule. Develop strategies and planning for consistent material availability for clinical manufacturing. <br> o Accountable for continuous material supply to support uninterrupted manufacturing, including adequate planning for long lead-time items, custom supplies and short expiry items.<br> o Identify, communicate/escalate and resolve any critical material supply issues; develop and execute risk mitigation plans.<br> o Assist in investigation and root cause analyses for any supply disruption or material quality issues.<br> o Collaborate with the procurement team to develop and manage key vendor relationship to ensure availability of critical materials and uninterrupted supply.<br> o Assist technical teams to get documents (such as Specification, Technical Data Sheet, etc.) related to materials from the vendors. <br><br>• Accountable to manage the Clinical Warehouse Operations.<br> o Manage the warehouse staff and warehouse areas; oversee material receipt (including Leukapheresis), storage, material movement, inventory control, and final product packaging and shipments.<br> o Develop, implement, and manage procedures (SOPs), processes, and systems related to the warehouse operations by determining material handling and storage requirements.<br> o Develop warehouse design by planning layout, product flow, and product handling systems, evaluating and recommending new equipment/Software.<br> o Develop warehouse operations system improvements by analyzing process workflow, staffing and space requirements, and equipment layout, implementing changes.<br> o Ensure inventory accuracy through cycle count and accurate and timely inventory adjustments.<br> o Directs the investigation of problems associated with incoming materials.<br><br>• Accountable for staffing plans, strategic/succession planning, personnel development, and performance management.<br> o Identify staffing requirements and build a strong team by recruiting and fostering development of empowered and diverse team members.<br> o Lead and motivate team members by providing feedback, coaching, and development opportunities.<br> o Responsible for creating role profiles for direct reports, establishing training curricula and ensuring that the requirements are met.<br> o Foster a culture of compliance and strong environmental, health, and safety performance.<br> o Promote a mindset of continuous improvement, problem solving, and prevention.<br><br>• Responsible for ensuring compliance with Federal (FDA, TSA, EPA, IATA, DOT, OSHA), State and local regulations. Ensure and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Practice.<br>• Manages deviations, quality events, change controls, and other Compliance related activities. Target zero overdue deviations. <br>• Accountable and responsible for providing audit support and remediation of audit findings.<br>• Apply 5S and Lean Principles to the area of responsibility.<br>• Responsible for establishing the Warehouse Business continuity strategy.<br>• Drive continuous improvements and support operational excellence in the area of responsibility.<br>• Participate in cross-functional teams to improve systems, processes, or internal/external performance.<br>• Supports the organization in the implementation of SAP.<br><br><br>[#video#{#400,300#}#/video#]