QC Analyst CAR-T

Johnson & Johnson Co.; Beerse; Sur place; EUR 55 000 - 74 000; Plein temps

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 compliance with GMP and company procedures. The role supports data integrity, audits, investigations, and continuous improvement while promoting a safe working environment.

Required: a scientific bachelor’s degree, 2+ years in a cGMP QC lab, experience with qPCR/Flow Cytometry/Potency Assays; CAR-T experience is highly desirable.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 2 years in a cGMP QC lab or similar.
• 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 QC laboratory technologies and compendial requirements (USP, EP, JP).
• Proficiency in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
• Excellent written and verbal communication skills in English; Dutch language skills are an advantage.
• Flexibility to work future Early and Late Shift schedules.

Responsabilités

• Perform analytical testing for final drug product release, stability studies, and incoming lentiviral batch identification in accordance with GMP requirements.
• 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 SME.
• Support laboratory investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance activities.
• Participate in internal and external audits, inspection readiness activities, and cross-functional forums.
• Deliver training within areas of expertise and promote a safe, compliant, and organized laboratory environment.

Connaissances

qPCR

Flow Cytometry

Potency Assays

GMP Compliance

SOP Development

Formation

Bachelor's degree in a scientific discipline

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 pay range and benefits for this position is:

Belgium - 54570EUR > 73830EUR gross per annum