QC Analyst CAR-T

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Non-Standard Job Sub Function: Workday Associate B Job Category: Non-Standard All Job Posting Locations: Beerse, Antwerp, Belgium

Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Job Description 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.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

#RPOEMEA #SCQuality

Required Skills: Preferred Skills: The anticipated base pay range for this position is: €0,00 - €0,00

Benefits:

• in addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Moreover, we offer 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.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.