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    18588 - Project Manager CAR-T J&J - Gent, België - Randstad

    Randstad
    Randstad Gent, België

    1 week geleden

    Randstad background
    Freelance
    Beschrijving

    CAR-T is an innovative treatment, which uses the power of the patient's own immune system. A patient's T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

    Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech 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.

    To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centres in the Ghent area (Belgium). The Project Lead Operations is part of the Operations workstream and closely connected to the Quality and Tech Transfer workstreams. This position will be based at our two new manufacturing facilities (Obelisc & Tech Lane) in the leading Biotechnology Hub of Ghent, Belgium.

    You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients.

    key responsibilities

  • As Project Lead Operations you will be responsible to drive the projects from an operational perspective related start/scale-up of the facility (ramp-up program, MES program). In a challenging, fast-paced environment, you play a central role in the organization to drive change, in which you will have a direct impact on the CAR-T program. By collaborating with various other functions (quality assurance, quality control, health and safety, information technology, operations, planning, etc.) you will support the start-up and scale-up of the CAR-T process. You take ownership for your projects in the Manufacturing process and will handle all related requirements, including the following responsibilities:
  • Act as project manager for operational projects related to the ramp-up program.
  • Have a 'boots on the ground mindset' to make sure that the actions are driven to execution.
  • Support the lean design and implementation of Information Technology systems (SAP, MES, S/4, ...)
  • including future releases to continuously improve performance and compliance.
  • Provide Operational expertise in the Technical Operations discussions based upon a combination of intensive GMP knowledge of ATMP's, knowledge in aseptic techniques and extensive process knowledge of cell and gene therapy products.
  • Immerse yourself in CAR-T processes, build up solid expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records etc., and ensure adequate training of the organization.
  • Ensure end-to-end overview of the flow of all material required in your area, including process material, documents, waste, samples.
  • Identify risks and opportunities in relation to process, contamination, cross-contamination and mix-up control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QA, QC and operations management.
  • Instil a mindset of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times.
    qualifications
  • Minimum 8 years of relevant work experience, preferably in aseptic manufacturing. Qualification & skills:
  • You have a Master's Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry ...).
  • You are an experienced project manager.
  • You have a strong knowledge in aseptic manufacturing.
  • You embrace diversity, equity, and inclusion.
  • You have detailed knowledge of the shop floor manufacturing process.
  • You have a start-up/can-do mindset, and you proactively search for solutions. - You prioritize, and provide clear instructions to peers.
  • You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution.
  • Your verbal and written communication skills enable you to influence without authority.
  • You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.
  • You are able to concisely summarize and present results.
  • Experience with team-based collaborations is a must.
  • Experience with equipment/systems commissioning/qualification/validation, IT systems, cell therapy (CAR-T) is an asset.
    key benefits As a consultant, in addition to your gross salary, you will also receive a number of benefits, including Lunch vouchers worth €7 Net expense allowance of €80 (untaxed) Hospitalisation insurance Car + fuel card (subject to conditions) OR commuting allowance 32 Holidays 13th month Group insurance ECO vouchers In addition, Randstad Professionals offers a range of training opportunities to help you develop your skills and, as a consultant, you will regularly be invited to fun Randstad events. At Randstad Professionals, we have something for everyone: we work as consultants on short and long-term projects, as well as on permanent contracts and self-employed assignments.
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