QC Analyst, CAR-T Biotech — GMP Quality Testing

Johnson & Johnson Co.; Beerse; Sur place; EUR 55 000 - 74 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a QC Analyst, CAR-T Biotech, to perform quality control testing for final drug product release and stability, ensuring compliance with GMP and company procedures. The role supports data integrity, audits, investigations, and continuous improvement while promoting a safe working environment.

Required: a scientific bachelor’s degree, 2+ years in a cGMP QC lab, experience with qPCR/Flow Cytometry/Potency Assays; CAR-T experience is highly desirable.

Qualifications

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

Responsabilités

• Perform analytical testing for final drug product release, stability studies, and incoming lentiviral batch identification in accordance with GMP requirements.
• Peer review of laboratory data to ensure accuracy, compliance, and data integrity.
• Author, revise, and maintain SOPs, Work Instructions (WIs), and protocols as a QC SME.
• Support laboratory investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance activities.
• Participate in internal and external audits, inspection readiness activities, and cross-functional forums.
• Deliver training within areas of expertise and promote a safe, compliant, and organized laboratory environment.

Connaissances

qPCR

Flow Cytometry

Potency Assays

GMP Compliance

SOP Development

Formation

Bachelor's degree in a scientific discipline

Description du poste

Johnson & Johnson is seeking a QC Analyst, CAR-T Biotech, to perform quality control testing for final drug product release and stability, ensuring compliance with GMP and company procedures. The role supports data integrity, audits, investigations, and continuous improvement while promoting a safe working environment.

Required: a scientific bachelor’s degree, 2+ years in a cGMP QC lab, experience with qPCR/Flow Cytometry/Potency Assays; CAR-T experience is highly desirable.