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Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview
The Warehouse Operations Manager will be responsible for the ramp-up, daily operational management, as well as continuous improvement of cGMP Warehouse Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products. This individual will partner Technical Operations with other functions to support the production and distribution of cell therapy products through safe and compliant operations according to cGMP requirements.
Major Responsibilities:
- Lead, direct, coach, and develop an effective Warehouse Operations team responsible for all inbound, outbound, material receipt & inventory management, and distribution processes for raw materials and final drug products.
- Establish a strong relationship between the different teams of the department by identifying clear roles and responsibilities.
- As a management member of the Warehouse team, participate in governances structure design, decision-making process, as well as performance management and initiatives related to the continuous improvement of the warehouse operations.
- Responsible for hiring, development, and performance management of staff (including shift teams) within the warehouse as well as the establishment of key performance indicators for Warehouse Operations
- Serve as key user of the S4 HANA EWM environment to represent the Warehouse & Operations business requirements and accuracy of inventory, processes and document track. Support implementation of improvement project to the EWM environment.
- Support the treatment and on time closure of deviations, Quality investigations and CAPA's related to operational activities. Ensure good CAPA effectiveness checks in order to keep standards on day-to-day activities and avoid recurrences.
- Take accountability for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS, security requirements. Develop solutions to enhance quality, efficiency, capacity, safety and security.
- Participate in or coordinate projects that involve operations (material flow, people flow, continuous improvement, ...)
- Interact with different stakeholders, internal (Training, Planning, QA, ...) or external (VWR, J&J, suppliers, …) to the department, on activities linked to his/her area of responsibilities.
- Be part of the EHS improvement and culture change inside the teams. Participate to risk assessments within the Warehouse. Ensure safety observations identified on operational activities are addressed and support implementation of improvements.
- Participate in and perform internal audits. Be one of the Warehouse spokespersons during internal and external inspections and audits (FAGG, …) for the subject of expertise managed in his/her area of responsibility if appropriated.
Qualification
Education
- University degree or relevant practical experience (Supply Chain, Logistics, ...)
- APICs CPIM certificate is desirable and a strong plus
Experience
- 3-5 years of experience in the warehouse and/or logistics operations manager role, preferably from pharmaceutical industry and in clinical supply
- Experience in people leadership and performance management.
- Experience in project management
- Experience with SAP
- Strong knowledge of GMP and GDP
Capabilities, Knowledge, and skills:
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Strength in communicating and working effectively with broad stakeholders in various scientific/technical/business disciplines.
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Very strong influencing capabilities with an ability to interact and communicate effectively at all levels of the organization and across different functions.
- Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.
- Advanced knowledge of warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment
- Advanced proficiency in the use of ERP systems, Warehouse Management Systems, and analytics
- Ability to promote a mindset of continuous improvement, problem solving, and prevention
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
