At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com/.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QC Biotech analyst, CAR-T Europe is responsible for preparing and conducting testing of the different samples taken during the production process. You are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.

You will be responsible for:

• Perform analytical testing in compliance with all applicable specifications, procedures, GMP regulations
• Maintain a safe work environment in compliance with all applicable environmental, health and safety regulations
• Perform peer review of laboratory data author and update SOPs, Wis and Protocols to support daily operations of the lab using the document management system
• Support laboratory related invetigation records and CAPAs
• Assist in the execution of internal audits and provide input to functional laboratory meetings
• Provide input and tak actions as a QC representative at cross-laboratory meetings SHE responsibilities:
• Always strictly apply all applicable prevention rules and procedures
• Make correct use of the personal and collective protective equipment provided, process and system ownership, ensuring order and tidiness
• Reporting (near) accidents, incidents, deviations and risky situations
• Conributing to and proposing solutions to improve safety, health and the environment
• Addressing other employees and third parties when prevention procedures are not followed or when unsafe behavior is reported

Qualification and requirements:

• A minimum of a bachelor’s degree in a Scientific or related field is required
• A minimum of two (2) years of experience working in a cGMP compliant QC laboratory or equivalent is required.
• Understanding of analytical data generated from performing biological and biochemical analytical techniques is required.
• Detailed knowledge of analytical technologies used in the QC laboratory (CAR-T experience) is required.
• Experience in performing cellular and/or molecular based techniques such as qPCR, Flow, Cytometry and/of Potency assays is required.
• Basic, kwowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is preferred.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required. Systems: eLims -SAP -Truvault -Summit