QA Lab Associate Car-t Ipl
Il y a 5 mois
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab associate for the CAR-T hub in Europe. The position will be based in Ghent 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 kill 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 IPL lab will perform the in process testing during the manufacturing process.
The QA Lab Associate IPL CAR-T is responsible for providing quality oversight for the site IPL laboratory, in accordance with Janssen policies, standards, procedures, and Global cGMP’s.
**Key Responsibilities**:
- Provide compliance oversight for the IPL laboratories, ensuring accurate and timely review of laboratory investigations, performing analysis on quality indicating data and identifying any trends noted for QC data.
- Support drafting and approving of standard operating procedures.
- Perform spot-checks in the IPL Lab. to ensure compliance with written regulations, policies, procedures, and global procedures.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
- Recognize patterns and trends in reported data and communicate to management.
- Provide guidance in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seeks management guidance on complex issues. Develops procedures.
- Be able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Identifies risk and develops contingency plans.
- Drive continuous improvement.
- Provide compliance oversight for analytical instrument qualification
**Qualifications**:
**Qualifications**:
**Education**:
- A minimum of a Master Degree in Engineering, Science or equivalent technical discipline is required.
**Experience and Skills**:
**Required**:
- A minimum of 2 years of experience in Quality Assurance
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- Excellent written and oral communication skills are required.
**Preferred**:
- Experience in biotechnology methods like flow cytometry, cell counting and viability is preferred
- Experience in cell culture is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
-
QA Lab and Data Integrity Management Car-t
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab and Data Integrity associate for the CAR-T hub in Europe. The position will be based in Gent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own...
-
Senior QA Associate Car-t
Il y a 5 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is op zoek naar een Senior QA Associate aan voor het CAR-T-hub in Europa. De functie zal gevestigd zijn in Gent, België. CAR-T (chimeric antigen receptor T-cell therapy) is een innovatieve aanpak om kankercellen te elimineren, waarbij gebruik wordt gemaakt van de kracht van het eigen immuunsysteem van de patiënt. Ze worden...
-
Sr. QA Associate Car-t Emea
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a Senior QA Associate for the CAR-T hub in Europe. The position will be based in Ghent 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...
-
Senior QA Associate Release Car-t Europe
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a Sr QA Associate for the CAR-T hub in Europe. The position will be based in Ghent 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...
-
Sr QA Associate Car-t Emea
il y a 1 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations/Project Support Lead for the CAR-T hub in Europe. The position will be based in Ghent 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...
-
QA/qp Operation Director Car T
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe.- 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...
-
QA Micro Associate
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinCAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results. We are therefore working passionately on expanding our...
-
QA Car-t Qualification Lead Emea
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe. **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...
-
QA Car-t Qualification Lead Emea
Il y a 7 mois
Gent, Belgique Johnson & Johnson Temps plein**CAR-T QA C&Q Engineer** The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a CAR-T QA C&Q Engineer for the CAR-T hub in Europe. **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....
-
QA Project Manager, Car-t Emea
il y a 1 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA Project Manager for the CAR-T hub in Europe. The position will be based in Ghent 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...
-
QA/qp Support Lead, Car-t Europe
Il y a 5 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA/QP Support Lead for the CAR-T hub in Europe. The position will be based in Ghent, Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells....
-
Associate Scientific Solutions Expert
Il y a 7 mois
Gent, Belgique Cerba Research Nederland Temps plein**The role** Cerba Research provides a one-stop clinical laboratory approach on a global level for more and more complex trials. Hereto, Cerba Research collaborates with different lab partners and subcontracted labs that need to be integrated within the Cerba Research network. At the same time, new diagnostic solutions need to be incorporated as well. As...
-
Senior Research Associate Discovery
il y a 4 semaines
Gent, Belgique Argenx Temps pleinWe are currently looking for an experienced research associate or associate scientist to join our dynamic R&D team at argenx, where we strive to innovate and deliver groundbreaking medicines to patients. We are seeking a dedicated and mature researcher who thrives in a fast-paced, collaborative environment. In this lab-focused role, you will plan, execute...
-
QA Release Supervisor
Il y a 6 mois
Gent, Belgique MindCapture Temps pleinQA RELEASE SUPERVISOR - Biotechnology- GhentABOUT THE COMPANY The **QA Release Supervisor** holds a pivotal role, ensuring the quality oversight of personalized cell therapy production for both clinical and commercial requirements within a sterile GMP environment. This position involves supervising QA release associates, collaborating with manufacturing to...
-
Research Associate
il y a 1 mois
Gent, Belgique Those Vegan Cowboys Temps pleinGot a heart full of wonder for protein science? Love the practical magic of making cow-free cheese? We’re on the lookout for a Research Associate to join our Fermentation team, where we work together to fine-tune and perfect microbial fermentation processes to bring recombinant proteins to life. If wranglin’ fermentation development excites you, it’s...
-
Sr. Manager Quality Systems
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a Senior Manager Quality System & Engineering for the CAR-T hub in Europe. The position will be based in Beerse or Ghent 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...
-
QA Lead Investigations
Il y a 5 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA Operations Lead Investigations, for the CAR-T hub in Europe. The position will be based in Ghent, Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate...
-
QA Csv Manager
il y a 7 jours
Gent, Belgique Cerba Research Temps pleinCerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...
-
(Associate) Technical Scientist
il y a 4 semaines
Gent, Belgique Argenx Temps pleinWe are currently looking for an (associate) technical scientist or senior research associate with demonstrated working experience in antibody discovery via phage display to join our dynamic R&D team at argenx, where we strive to innovate and deliver groundbreaking medicines to patients. Location: This position is located in Zwijnaarde (Ghent) and requires...
-
QA Specialist
Il y a 5 mois
Gent, Belgique MindCapture Temps pleinQA SPECIALIST - Biotech- GhentWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success. We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on...
