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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 Project Specialist will be responsible for process improvements and 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:
- Recruit, lead, and coach a team of Warehouse Project Specialists to support warehouse & logistics operations continuous improvement objectives and initiatives, and define & manage projects to achieve and realize them.
- Support and working with company's training department, map capabilities within the team, support the set-up of training programs and development paths, perform regular evaluations and review sessions to ensure process compliance of the operations.
- Define Project management KPI's in line with Lean Six Sigma, DMAIC and additional relevant project management tools. Present and report project deliverables to peers and Senior Management. Plan the project timeline according to resource availability, capability of the warehouse team, and serve as point of contact to company's PMO organization, in supporting the company/corporate programs from the warehouse team perspective (material flow, people flow, continuous improvement, ...).
- Support the creation, monitoring, scheduling, and implementation of projects related to the Warehouse & Operations business requirement. Align with all involved stakeholders to meet the GXP requirements.
- Serve as lead person from the warehouse functions in leading functional Quality Investigation related activities and accountable for on time closure of deviations, Quality investigations and CAPA's related operational activities. Ensure good CAPA effectiveness checks in order to maintain quality and compliance on day-to-day activities.
- Take accountability for warehouse & logistics 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.
- 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. Sponsor safety within the organization
- Participate in and perform internal audits. Responsible for documentation improvements and warehouse & logistics related GMP procedures. Lead the review and improvement and/or update SOP and WI together with internal stakeholders to comply with legal, safety and quality standards.
- Train and evaluate the functional organization in the compliant execution of SOP and WI related to Warehouse & Operations business requirements.
Qualification
Education
- University degree or relevant practical experience (Supply Chain, Warehouse Operations, Logistics Operations, ...)
- 5+ years of experience in supply chain or equivalent with continuous improvement background and management
Experience
- 5 to 8 years of project/program management experience, preferably in the pharmaceutical industry and in clinical supply
- Experience in process engineering, 5S, and continuous improvement
- Experience and strong affinity with QI & deviation management
- Strong knowledge of GMP and GDP
- Initial people management and coaching experience
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.
