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.
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.
- 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)
- To stay 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.
- 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
- 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&T team or colleagues development
- To provide training support for data, knowledge, Investigation and product mastery
- To establish a strong network among J&J and across different departments
- To build strong partnerships in a matrixed environment, i.a. by liaising with different internal cross-functional teams such as Manufacturing (Operations), QC (IPL), Supply Chain, Engineering and Quality, as well as effectively integrating with external collaborators, to drive projects/programs forward and ensure efficient execution of process validation and production schedules (clinical and commercial)
- To ensure seamless flow of knowledge and information across functions, departments, and with other sites when applicable, resulting in fast and effective resolution of issues
- To participate of key/industry leading conferences, job days and other opportunities to promote the organization and CAR-T technology
A minimum of a Master’s degree in Engineering, Science, Pharmacy or related field or equivalent experience required. Advanced degree preferred.
Minimum 4 -7 years of operations experience within a cGMP environment (manufacturing/quality/development) in the biotech/biopharma industry and preferably cell/gene therapy.
Capabilities, Knowledge, and skills:
- Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
- Ability to work independently and successfully under minimal supervision and integrate cross-functional issues and balance competing priorities effectively.
- Data analysis, data life cycle management.
- Statistical Process Control
- Born team player.
- Excellent scientific writing
- Being able to manage shifting priorities and multiple tasks simultaneously to meet critical deadlines in a fast paced and dynamic, growing environment.
- Positive and pro-active
- Results driven while working within GMP framework of procedures and rules.
- Excellent organizational skills.
- Strong analytical mind, problem solving and critical thinking Being able to trouble shoot and resolve complex scientific/technical problems.
- Advanced computer skills and practical knowledge.
- Clear communicator with ability to build strong partnerships.
- Accurate, Authentic, Transparent, Passionate, Fearless and Accountable.
- Coaching skills, being approachable, motivational and active listening.
- Ability to lead with influence as a change agent to promote flexibility, creativity, and accountability.
- Eager for improvement and efficiency increase.
Dutch (at least fluent) and English
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.