Cell Processing Manager

 

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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, innovative 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 Manager is part of the Operations Leadership Team. He/She leads part of the Operations Workstream and is 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.

Roles & responsibilities:

As Cell Processing Manager, you will act as a decision maker in the Operations workstream, with responsibilities in setting-up, maintaining and improving the Manufacturing Process Operations System.
In a challenging, fast-paced environment, you play a central role in the organization, collaborating with various other functions (quality assurance, quality control, health and safety, information technology, operations, planning, etc.) to support the successful transfer of the CAR-T process, the timely start of clinical and commercial manufacturing and further improvement of the process.
You take ownership of your specific area of the Manufacturing process and will handle all related requirements, including the following responsibilities:

• Be accountable for Operations in one of the two CAR-T Manufacturing sites and act as a lead for improvement your area.
• Provide Operational direction 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.
• Be an expert in the CAR-T processes and Aseptic Manufacturing, 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 seamless flow of Operational knowledge and information across functions, and with other sites when applicable.
• Operational review and approval of documentation related to your area, including FMEA’s, SOP’s, Protocol’s.
• 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 approver of change controls.
• 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.
• 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.
• Build a sustainable partnership with Legend Biotech and develop an appropriate governance structure to monitor the daily/weekly/monthly operational and quality performance.
• Coach your team to ensure that your area is successful.
• Coach 3 – 5 people to assist in their further development.

Qualifications

Experience
Minimum 7 - 10 years of relevant work experience.

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 act as an example for your team (direct leadership) and the wider organization (indirect leadership), to ensure a right-first-time and continuous improvement mindset.
• You have a wide vision to ensure that, next to taking operational responsibilities, other requirements (e.g. QA, QC, Commissioning/Qualification) are taken into account.
• You are able to 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 in equipment/systems commissioning/qualification/validation, IT systems, cell therapy (CAR-T) is an asset.

Our offer

• 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.

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