QC Analyst CAR-T

Job title: QC Analyst CAR-T

The QC Analyst, CAR-T Biotech is responsible for performing quality control testing related to final drug product release, stability testing, and incoming lentiviral batch identification testing. The role ensures that all laboratory activities are executed in compliance with GMP regulations, company procedures, and quality standards. As a key member of the QC team, the analyst supports laboratory operations, data integrity, audit readiness, investigations, documentation, equipment maintenance, and continuous improvement initiatives while contributing to a safe and compliant working environment.

Key Responsibilities

• Perform analytical testing for final drug product release, stability studies, and incoming lentiviral batch identification in accordance with GMP requirements and approved procedures.
• Conduct 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 Subject Matter Expert (SMe).
• Support laboratory investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance activities.
• Participate in internal and external audits, inspection readiness activities, laboratory meetings, and cross-functional collaboration forums.
• Deliver training within areas of expertise and promote a safe, compliant, and organized laboratory environment, including adherence to SHE (Safety, Health & Environment) standards.

Requirements

• Bachelor's degree in a Scientific discipline or a related field.
• Minimum of 2 years of experience in a cGMP-compliant Quality Control laboratory or similar regulated environment preferred.
• 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 biological and biochemical analytical testing, with knowledge of QC laboratory technologies and preferably compendial requirements (USP, EP, JP).
• Proficiency in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
• Excellent written and verbal communication skills in English; Dutch language skills are an advantage.
• Flexibility to work future Early and Late Shift schedules may be required.

Benefits

• In addition to base pay, we offer benefits such as an annual bonus with set target depending on pay grade/location, vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health, service anniversary and recognition awards, and participation in several insurance plans where applicable.