Senior Manager, Warehouse Operations

Position Summary
We are seeking a highly motivated Senior Manager, Warehouse Operations who will be responsible for leading a high performing team responsible for all processes associated with material receipts, movement, storage, and distribution of clinical and commercial cell therapy drug products that will be manufactured within a state-of-the-art multi-product cell therapy manufacturing facility. This individual will play a critical role in the warehousing processes ensuring appropriate controls, complete traceability, and efficient operations to support the production of cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. This individual will lead different operations within the warehouse with multiple shifts while providing strategic and operational efficiencies, cost savings, inventory accuracy and leadership actions. These operations may include general warehousing, material kitting, cold chain operations and dispensary activities. This position assures individual compliance with all FDA and regulatory agencies and applicable policies, regulations and certifications including training, documentation, standard operating procedures, and corporate policies. The Senior Manager will maintain a compliant, effective, safe and efficient operation that meets or exceeds site goals and objectives. This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Manufacturing, MS&T, Quality Assurance, QC, Process/Analytical Development, Supply Chain, Training, Engineering/Facilities, HS&E, and Finance. The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Lead, direct, coach, and develop an effective Warehouse team supporting the production of clinical and commercial production within a state-of-the art multi-product cell therapy manufacturing facility. Effectively interface and collaborate with key stakeholders and functions
• Operate within the requirements of a validated warehouse management system, manage daily operational activities associated with the receiving of Apheresis and PBMC shipments, all inbound movement / receipt and storage of materials through the supply chain network, kitting operations along with the preparation of drug product shipments, and internal dispensary operations
• Maintain shipping, receiving, staging, kitting, and storage areas that are compliant, efficient, effective, and safe
• Engage with various groups to manage and expedite receipt along with ensuring appropriate sampling / inspection of incoming materials
• Manage the creation, implementation and compliance for all Warehouse documentation, procedures, and policies, including materials management, cycle counting, etc.
• Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources
• Build and maintain systems to continuously monitor, analyze, and optimize Warehouse Operations and support and own Warehouse Quality events, including change controls, investigations, and CAPAs
• Oversee the hiring, development, and performance management of staff within the Warehouse
• Lead and actively participate in all regulatory and internal audits of the facility
• Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
• Build Operational Excellence capabilities through training, and continuous improvement tools and events such as 5S assessment and Kaizen within the Warehouse

Requirements

• Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields
• 10+ years of experience within a cGMP environment in the biotech/biopharma industry concentrated within Warehouse Operations, Manufacturing, and Supply Chain
• 5+ years leadership experience
• Advanced proficiency in SAP S/4 Hana ERP system/WMS Applications and analytics tools
• Cell/Gene Therapy and CDMO experience preferred
• Advanced knowledge of warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification
• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
• Advanced knowledge of Quality and Compliance systems
• Advanced knowledge of OSHA, DEA, USP and other applicable WH regulations
• Advanced project management experience handling multiple projects simultaneously
• Advanced proficiency in data analytics and process mapping applications (Excel, Visio, SharePoint)
• Understanding of cell culture, cryopreservation, purification, and aseptic processing