QC Analyst CAR-T Biotech

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health insurance

Résumé du poste

Johnson & Johnson seeks a QC Analyst (CAR-T Biotech) to perform quality control testing for final drug product release and stability, ensuring GMP compliance. The role supports investigations, data integrity, and continuous improvement within a fast-paced biopharma setting.

The candidate will contribute to audit readiness, SOP maintenance, and collaboration across cross-functional teams while upholding SHE standards and training colleagues.

Qualifications

• Requires a Bachelor's degree in a scientific field.
• Minimum 2 years in a cGMP QC lab or similar regulated environment.
• Experience with cellular/molecular analytic techniques (qPCR, Flow Cytometry, Potency Assays).

Responsabilités

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

Connaissances

Attention to detail

GMP knowledge

Data integrity

Communication skills

MS Office (Excel, Outlook)

Formation

Bachelor's degree in a Scientific discipline

Outils

qPCR

Flow Cytometry

Potency Assays

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

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.

Required Skills

Preferred Skills

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

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.
• 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
• employees - and in some location’s eligible dependents - can participate in several insurance plans.

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 https://www.jnj.com/.