Are you inspired to make a big difference in the life expectancy of our patients?
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 centers in the Ghent area (Belgium).
The Cell Processing Engineer 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.
Roles & responsibilities:
As Cell Processing Engineer you will act as a decision maker in the Operations workstream, with responsibilities in setting-up, maintaining and improving a part of the Manufacturing Process Operations System.
In a challenging, fast-paced environment, you play a central role in the organization, in which you will have a direct impact on the CAR-T program by gaining detailed process knowledge and by building a sustainable and large network.
By collaborating with various other functions (quality assurance, quality control, health and safety, information technology, operations, planning, etc.) you will support the successful transfer of the CAR-T process, the timely start of clinical and commercial manufacturing and further improvement and scale-up of the process.
You take ownership for your specific area of the Manufacturing process and will handle all related requirements, including the following responsibilities:
- Identify opportunities for improvement in your area and lead their development and implementation
- 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.
- Operational assessor of change controls for your area.
- Act as a lead in root cause related to safety/quality issues in your area.
- Act as a spokesperson for your area during health care inspections.
- Support the lean design and implementation of Information Technology systems (SAP, MES, S/4, …) including future releases to continuously improve performance and compliance.
- As Ops SME, represent Operations in Process Design and Process Qualification.
- Instill 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.
- Daily participation in the Operational governance meetings (Tier 2, Change control board, QIP …) and frequent presence on the manufacturing shop floor (incl. grade B).
- Build a sustainable partnership with Legend Biotech and develop an appropriate governance structure to monitor the daily operational performance.
- Furthermore, a large portion of your time will be focused on developing detailed knowledge of the CAR-T production system:
- Develop & maintain in depth understanding of the mfg. processes (incl. sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
- Develop & maintain robust understanding of aseptic and cell processing techniques.
- Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP, basic understanding of TE)
- Develop technical writing proficiency (especially in view of development of instructions and contribution to investigations)
- Develop general understanding of immunology, the products and field of application of products in scope.
- Develop understanding of the content of the regulatory filings (CMC sections related to the production system)
- Become part of the global knowledge networks (global MSAT, MSQA, JJRC, DPDS …), develop connections with peers in Raritan, CMO
- Understand biosafety.
Minimum 5 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 place our patients at the center of everything you do.
- You embrace diversity, equity, and inclusion.
- You have strong knowledge of aseptic manufacturing.
- 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.
- The opportunity to participate in a progressive treatment that gives hope to patients in need.
- The ability to help shape a new venture from the start.
- An innovative working environment.
- Training on the job for this specific treatment.
- Opportunities to continue to develop and grow in an extensive and strong organization.
- An open-ended contract and a competitive remuneration package.