CAR-T QC Analyst: GMP-Driven Quality & Impact

jj; Beerse; Sur place; EUR 55 000 - 74 000; Plein temps

Résumé du poste

Johnson & Johnson in Beerse, Belgium, seeks a QC Analyst, CAR-T Biotech to execute quality control testing for final drug product release, stability studies, and lentiviral batch identification in a GMP environment.

You will support data integrity, investigations, documentation, and training, while helping ensure a safe, compliant lab. A BSc in a scientific field and 2+ years in a cGMP QC setting are required; CAR-T experience is highly desirable.

Qualifications

• Bachelor's degree in a Scientific discipline or related field.
• Minimum of 2 years of experience in a cGMP-compliant QC lab or similar.
• Experience with cellular/molecular analytical techniques (qPCR, Flow Cytometry, Potency Assays).
• Strong knowledge of QC laboratory technologies and compendial requirements (USP/EP/JP).
• Proficiency in Microsoft Office (Outlook, Excel, Word, PowerPoint).
• Excellent written and verbal communication in English; Dutch an advantage.

Responsabilités

• Perform analytical testing for final drug product release, stability studies, and lentiviral batch identification in accordance with GMP.
• Peer review of laboratory data for accuracy and integrity.
• Author/revise/maintain SOPs, WIs, and protocols as QC SME.
• Support investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance.
• Participate in audits, inspections, lab meetings, and cross-functional forums.
• Deliver training and maintain a compliant, safe laboratory environment.

Connaissances

English communication

Lab techniques

Formation

Bachelor's degree in science

Outils

qPCR

Flow Cytometry

Potency Assays

Description du poste

Johnson & Johnson in Beerse, Belgium, seeks a QC Analyst, CAR-T Biotech to execute quality control testing for final drug product release, stability studies, and lentiviral batch identification in a GMP environment.

You will support data integrity, investigations, documentation, and training, while helping ensure a safe, compliant lab. A BSc in a scientific field and 2+ years in a cGMP QC setting are required; CAR-T experience is highly desirable.