Qc Micro Analyst, Car-t Europe
il y a 3 jours
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting QC Micro analysts for the CAR-T hub in Europe. The position will be based in Beerse Belgium.
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 Micro 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.
**Qualifications**:
Major Responsibilities:
- 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 investigation records and CAPAs.
- Assist in the execution of internal audits.
- Provide input to functional laboratory meetings.
- Provide input and take actions as a QC representative at cross-laboratory meetings.
Qualifications:
- 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 data generated from performing microbiological techniques is required.
- Detailed knowledge of Microbiological technologies, aseptic techniques used in the QC micro laboratory (CAR-T experience) is required.
- Experience in performing endotoxin testing, grow promotion testing, sterility testing & environmental monitoring testing is required.
- Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is preferred.
- Excellent written and oral communication skill are required.
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