QC Analyst CAR-T

Johnson & Johnson Innovation

Antwerpen

Sur place

EUR 50 000 - 70 000

Plein temps

Il y a 12 jours
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Avantages offerts par ce poste

Annual bonus
Vacation days
Well-being reimbursement
Insurance plans

Résumé du poste

Johnson & Johnson is seeking a QC Analyst, CAR-T Biotech to perform quality control testing for final drug product release and stability, ensuring GMP-compliant laboratory practices. You will support data integrity, investigations, and documentation while contributing to a safe, compliant work environment.

The role involves reviewing data, maintaining SOPs, and participating in audits, with a focus on CAR-T related assays and biotech QC processes.

Qualifications

  • Bachelor's degree in a Scientific discipline (or related field) is required.
  • 2+ years in a cGMP Quality Control lab or similar regulated setting preferred.
  • Experience with cellular and/or molecular analytical techniques (qPCR, flow cytometry, potency assays); CAR-T experience is desirable.

Responsabilités

  • Perform analytical testing for final drug product release and stability per GMP procedures.
  • Peer-review laboratory data for accuracy and compliance.
  • Author and maintain SOPs, WIs, and QC protocols as SME.
  • Support investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance.
  • Participate in audits, inspections, and cross-functional collaboration.
  • Deliver training and promote a safe, compliant laboratory environment.

Connaissances

qPCR
Flow Cytometry
Potency Assays
CAR-T experience
GMP knowledge
SOP writing and QA support
MS Office

Formation

Bachelor's degree in a Scientific discipline

Outils

Microsoft Excel

Description du poste

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

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.

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