Qc Car-t Trainer Expert
Il y a 9 mois
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting QC CAR-T Trainer Experts 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 operate from the existing Janssen Beerse site.
The QC CAR-T Trainer Expert is responsible for preparing and coaching newly onboarded QC CAR-T analysts. The QC analysts perform QC release/stability testing of the different samples taken during the production process or perform qualification of critical reagents utilized in the QC release analyses. You are responsible for ensuring that trained and qualified QC analysts perform testing in compliance with all applicable procedures, standards, and GMP regulations.
**Qualifications**:
Major Responsibilities:
- Coach analysts in performing 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.
- Provide QC analysts theoretical background on CAR-T and QC related analytical methods.
- Train QC analysts in QC related analytical methods being used in CAR-T release.
- Author and update SOPs, WIs and Protocols to support daily operations of the lab using the Document Management System.
- Support laboratory related investigation records, CAPAs and assist in complex laboratory investigation issues by demonstrating strong reasoning skills.
- Assist in the execution of internal audits.
- Provide input to functional laboratory meetings.
Qualifications:
- Detailed knowledge of Flow cytometry, ELISA, qPCR and cell culture with hands-on experience is required.
- Understanding of analytical data generated from performing biological and biochemical analytical techniques is required.
- Experience in coaching people is required.
- Strong communication and interpersonal skills, a high level of organizational ability, attention to detail, and ability to work effectively in a collaborative environment globally (US and EU) is required.
- Knowledge of cGMP regulations and FDA/EU guidance is preferred.
- Comfortable with speaking and interacting with inspectors.
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