Warehouse Process Specialist
il y a 1 semaine
**Company Information**
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.
**Position Overview**
The Warehouse Process Expert will be responsible for supporting the operational and project team 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**
- Serve as the Subject Matter Expert (SME) for all GMP process related activities in the Warehouse Operations, including but not limited to Apheresis, Cold/Frozen, Final DP, Ambient, General warehouse operations. Be a SAP S/4 HANA key user and serve as the first line of contact for system related questions within the operational team.
- Support the implementation of projects to the warehouse operational team related to the Warehouse & Operations business requirement. Align with all involved stakeholders to meet the GxP requirements and project deliverables. Be the bridge between the warehouse operational team and the project team to implement changes and improvements on the shop floor.
- Perform and support the functional QI (Quality Investigations) activities and ensure on time closure of deviations, Quality investigations and CAPA's related to operational activities. Ensure good CAPA effectiveness checks on day-to-day activities by working closely with the operational team.
- Train and evaluate the functional organization in the compliant execution of SOP and WI related to Warehouse & Operations business processes. Set up and guide on-the-job training schedules for on boarders and assess where additional training is needed within the warehouse operational team. Support company training department, map skills within the operational team, monitor timely training completeness to ensure operational taskforce always stays in GMP compliance.
- Take accountability for best practices implementation as per GxP requirements and quality standard. Ensure compliance of operational activities with GxP, and company policies of quality, training, EHS, security domains.
- 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 and/or project scope
- 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
**Qualification**
**Education**:
3+ years of experience in supply chain or equivalent with continuous improvement background, preferably in the pharmaceutical industry and in clinical supply
**Experience**:
- SME for operational processes within Warehouse Operations.
- Experience and strong affinity with SAP would be ideal but not a must
- Experience and strong affinity with quality investigations as well as deviation management
- 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 proficiency in the use of ERP systems, Warehouse Management Systems, and analytics
- Ability to promote a mindset of continuous improvement, problem solving, and prevention.
**Language(s)**:
Fluent in English, preferably fluent in Dutch
LI-AG1
Legend Biotech maintains a drug-free workplace.
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