QC Analyst, CAR-T Biotech: GMP Quality & Impact

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson’s Innovative Medicine QC team seeks a QC Analyst (CAR-T Biotech) to perform analytical testing for final drug product release, stability, and batch identification. You will ensure GMP compliance, data integrity, and support investigations in a fast-paced lab.

The role requires a scientific degree and 2+ years in a regulated QC lab, with expertise in qPCR, Flow Cytometry, Potency Assays, and strong English communication. Dutch is a plus; be prepared for early/late shifts.

Qualifications

• Bachelor's degree in a scientific field; 2+ years in a cGMP QC lab or similar regulated setting preferred.
• Experience with cellular/molecular analytics: qPCR, Flow Cytometry, Potency Assays; CAR-T experience desirable.
• Strong knowledge of QC laboratory technologies and regulatory requirements (USP, EP, JP).

Responsabilités

• Perform analytical testing for final drug product release and stability per GMP and procedures.
• Peer review laboratory data for accuracy, compliance and integrity.
• Author/revise QC SOPs, Work Instructions and protocols as SME.
• Support investigations, deviations, CAPAs, equipment qualification and maintenance.
• Assist audits and inspection readiness; participate in cross-functional meetings.
• Deliver training and promote a safe, compliant lab environment adhering to SHE standards.

Connaissances

qPCR

Flow Cytometry

Potency Assays

GMP compliance

English communication

Microsoft Office

Dutch language (advantage)

Formation

Bachelor's degree in science or related field

Description du poste

Johnson & Johnson’s Innovative Medicine QC team seeks a QC Analyst (CAR-T Biotech) to perform analytical testing for final drug product release, stability, and batch identification. You will ensure GMP compliance, data integrity, and support investigations in a fast-paced lab.

The role requires a scientific degree and 2+ years in a regulated QC lab, with expertise in qPCR, Flow Cytometry, Potency Assays, and strong English communication. Dutch is a plus; be prepared for early/late shifts.