Knowledge & Data Management Associate

il y a 4 semaines

Gent, Belgique Legend Biotech EU Temps plein

**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.

**Role Overview**

The CAR-T Knowledge & Data management Associate will be **part of the MS&T** **team** and will be responsible to provide:

- Inputs to build capability and improve Product Quality, Safety and Efficiency.
- A **comprehensive dashboard** intended to proactively track data from multiple environments like MES/LIMS/SAP, etc.

**Major Responsibilities**:
**Process Robustness**:

- To support project validation milestones & the operations
- To support the establishment of a **Process History File** (= central repository of historical knowledge of the process) and to ensure associated maintenance
- To provide technical and data **analysis expertise** in the Technical Operations group for the cell and gene therapy manufacturing process technology to support technical activities for transfers into and out of the Raritan facility
- To contribute to **seamless proactive flow of knowledge and information across functions**, and with other sites when applicable
- To analyze deviations, events and key process parameters aiming to provides reports to MS&T department on **trending and status** as requested
- To maintain various **databases** of production information
- To coordinate **data collection and trend analysis** as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR)
- To support **best-in-class end-to-end electronic data management for CAR-T product** development and manufacturing
- To perform **routine analysis of data to monitor whether the process remains in a state of control, to be able to identify trend **proactively****:

- To support investigators to provide data summaries, dashboard, relevant data for **deviation investigation**. Support investigators with statistical analysis as needed
- To support data inquiries / provision of data for manufacturing / clinical / commercial analyses, regulatory filings, quality investigations
- To contribute to the interface with **CPV** team (Ghent, Raritan & others if needed)
- To support the **data flow mapping / establishment**:

- To be the SPOC of **statistical evaluations **(Ghent, Raritan & others if needed)
- To support validation investigations all along the validation stages
- To support investigation on Aseptic purposes / Sterility Assurance
- To interface with J&J colleagues and QC IPL
- To support the investigation house
- To support the life cycle of our product(s)
- To ensure a **permanent connection with the shopfloor** close to operators, with a focus on data
- To own the **process knowledge** of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving
- To Support manufacturing team to **troubleshoot and resolve complex scientific/technical problems.**

**Quality & Compliance**:

- To ensure appropriate compliance for the capture of the **various categories of data generated (21 CFR Part 11) and other** adequate regulations
- To feed the **PQR** with relevant statistical evaluations
- To review / challenge **CPV protocols & reports**:

- To review / evaluate / challenge **data analysis tool(s)**:

- **T**o s**tay up to date with regulatory requirements and state of the art guidelines, maintain permanent inspection readiness**, actively support regulatory inspections and preparation thereof as SME, and support the implementation of actions resulting from such inspections.
- **To draft, feed, review/revise, and/or support writing of (not limited to & upon needs)**:

- Investigations (incl. impact and risk assessments, corrections, CAPAs)
- Change controls
- Development reports
- Qualification and validation protocols and reports
- Technical assessments and rationales
- SOPs and work instructions
- Batch records
- To continuously maintain compliance with internal training requirements
- **To recognize and act on potential compliance issues and opportunities for process changes/improvement.**

**Continuous Improvement**:

- To support **digitalization initiative(s)**:

- To support the continuous improvement related to **data management lifecycle**:

- To support the **lean** approach to knowledge management
- To ensure a smooth, user-friendly and **robust knowledge accessibility**:

- To promote **a culture of data integrity**

**Development/Role Specific**:

- To liaise with Raritan ME **key partners**:

- To share and manage **the Process History File** (PHF)
- To be involved and actively contribute to **data management initiatives**:

- To **actively and continuously develop** and to support MS&

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