QC Analyst CAR-T Biotech

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 42 000 - 68 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine invites a QC Analyst, CAR-T Biotech to join our Beerse, Belgium site. You will perform analytical testing for final drug product release and stability, ensure data integrity, and help maintain GMP-compliant laboratory operations.

You will author SOPs and support audits, training, and cross-functional collaboration. The role requires a scientific degree and at least 2 years in a regulated QC lab, with qPCR/Flow Cytometry/Potency Assays experience highly

Qualifications

• Bachelor's degree in a scientific field.
• Minimum of 2 years in a cGMP QC lab or regulated environment.
• Experience with qPCR, Flow Cytometry, Potency Assays; CAR-T experience desirable.
• Knowledge of QC lab technologies and compendial requirements (USP/EP/JP).
• MS Office apps including Outlook, Excel, Word, PowerPoint.
• Strong English communication; Dutch is an advantage.
• Flexibility for upcoming Early and Late shifts.

Responsabilités

• Perform analytical testing for final drug product release, stability studies, and lentiviral batch ID per GMP.
• Peer review laboratory data for accuracy, compliance and data integrity.
• Author, revise, and maintain SOPs, WIs, and QC protocols as SME.
• Support investigations, deviations, CAPAs, equipment qualification, calibration and maintenance.
• Participate in audits, inspection readiness, and cross-functional meetings.
• Deliver training and maintain a safe, compliant lab with SHE standards.

Connaissances

qPCR

Flow Cytometry

Potency Assays

Data integrity

MS Office

Formation

Bachelor's degree in a Scientific discipline

Outils

Outlook

Excel

Word

PowerPoint

Description du poste

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.

Here’s What You Can Expect:

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA #SCQuality

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.