QC Analyst Biotech

Johnson & Johnson Innovative Medicine; Beerse; On-site; EUR 55,000 - 74,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Recognition awards

Job summary

Johnson & Johnson Innovative Medicine in Beerse is seeking a QC Analyst for the CAR-T Europe program. You will perform analytical testing and ensure GMP-compliant operations to support CAR-T manufacturing and related labs.

Required are a bachelor’s degree in a scientific field and at least 2 years in a cGMP QC lab, plus experience with qPCR, flow cytometry, and potency assays. Weekend shifts may be needed.

Qualifications

• Bachelor’s degree in a scientific field required.
• At least two years in a cGMP QC lab environment.
• Knowledge of biological/biochemical analytical data.
• CAR-T related analytical technologies and aseptic techniques.
• Experience with qPCR, Flow Cytometry, and potency assays.
• Familiarity with compendial requirements (USP/EP/JP) preferred.
• Proficient in MS Office; strong written and oral communication.
• Weekend shift may be required for clinical/commercial demand.

Responsibilities

• Perform analytical testing in compliance with specifications and GMP.
• Maintain a safe, compliant laboratory environment.
• Peer review of laboratory data.
• Author and update SOPs, WIs, and protocols for daily lab operations.
• Support laboratory investigations and CAPAs.
• Assist in internal audits.
• Provide input at cross-laboratory QC meetings.

Skills

cGMP QC

CAR-T experience

qPCR

Flow cytometry

Potency assays

Aseptic techniques

Biochemical analysis

MS Office

Written & oral communication

Education

Bachelor’s degree in a Scientific or related field

Tools

Document Management System

Job description

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

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting QC analysts for the CAR-T hub in Europe. The position will be based in Beerse Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QC Biotech analyst, CAR-T Europe is responsible for preparing and conducting testing of the different samples taken during the production process. You are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.

Major Responsibilities:

• Perform analytical testing in compliance with all applicable specifications, procedures, GMP regulations
• Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Perform peer review of laboratory data
• Author and update SOPs, WIs and Protocols to support daily operations of the lab using the Document Management System
• Support laboratory related investigation records and CAPAs
• Assist in the execution of internal audits
• Provide input to functional laboratory meetings
• Provide input and take actions as a QC representative at cross-laboratory meetings

Qualifications:

• A minimum of a bachelor’s degree in a Scientific or related field is required
• A minimum of two (2) years of experience working in a cGMP compliant QC laboratory or equivalent is required.
• Understanding of analytical data generated from performing biological and biochemical analytical techniques is required.
• Detailed knowledge of analytical technologies and aseptic techniques used in the QC laboratory (CAR-T experience) is required.
• Experience in performing cellular and/or molecular based techniques such as qPCR, Flow Cytometry, and/or Potency assays is required.
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is preferred.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required.
• Excellent written and oral communication skill are required

In a later Phase - Candidates must be able to accommodate a weekend shift schedule as required by clinical / commercial demand.

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.

Required Skills:

Preferred Skills:

The anticipated pay range for this position, in the primary posting location, is:

€0,00 - €0,00

The anticipated pay ranges for additional locations are:

Belgium - 54570 EUR - 73830 EUR

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.