CAR-T QC Analyst: GMP Quality, Data Integrity, Training

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium, is seeking a QC Analyst, CAR-T Biotech, to perform quality control testing and support GMP-compliant drug product release. The role emphasizes data integrity, SOPs, and investigations.

The candidate will work in a cGMP environment with responsibilities spanning stability testing, audits, and cross-functional collaboration, contributing to a safe and compliant lab culture.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 2 years in a cGMP QC laboratory or similar regulated environment.
• Experience with cellular and/or molecular analytical techniques such as qPCR, Flow Cytometry, and Potency Assays; CAR-T experience is desirable.
• Strong understanding of biological and biochemical analytical testing, with knowledge of QC lab technologies and compendial requirements (USP, EP, JP).
• Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint.
• Excellent written and verbal communication in English; Dutch is an advantage.
• Flexibility to work Early and Late Shift schedules may be required.

Responsabilités

• Perform analytical testing for final drug product release, stability studies, and lentiviral batch identification.
• Conduct peer review of laboratory data for accuracy and data integrity.
• Author and maintain SOPs, WIs, and protocols as QC SME.
• Support investigations, deviations, CAPAs, and equipment qualification.
• Participate in audits, inspection readiness, and cross-functional meetings.
• Deliver training and promote a safe, compliant laboratory environment.

Connaissances

qPCR

Flow Cytometry

Potency Assays

CAR-T

Formation

Bachelor’s degree in a scientific discipline

Outils

MS Office

Description du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium, is seeking a QC Analyst, CAR-T Biotech, to perform quality control testing and support GMP-compliant drug product release. The role emphasizes data integrity, SOPs, and investigations.

The candidate will work in a cGMP environment with responsibilities spanning stability testing, audits, and cross-functional collaboration, contributing to a safe and compliant lab culture.