Qc /ems Analyst

il y a 1 semaine

Gent, Belgique Legend Biotech US Temps plein

**Company Information**

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

**Role Overview**

The QC/EMS Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing and routine Environmental Monitoring sampling related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

**Major Responsibilities**:

- Responsible for the completion of QC testing and for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
- Ensure QC testing and microbiological control strategy is completed in compliance with all applicable procedures, standards and GMP regulations.
- Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to the cGMP facility to manufacture products.
- Conduct analytical testing of utility and in-process samples submitted to the QC laboratories.
- Participate in training and delivery of Operations aseptic technique and microbiology awareness training program.
- Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Create, review and approve relevant QC documents, SOP's and WI's.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.

**Qualification**

**Education**:
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.

**Experience**:
**Capabilities, Knowledge, and skills**:

- Experience in a Quality Control setting is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of CAR-T QC test methods and related equipment is preferred
- Excellent written and oral communication skills are required
- Comfortable with speaking and interacting with inspectors.
- This position may require occasional travel to partner sites as business demands (max 10%).

**Language(s)**:
Dutch

Technical English

LI-AG1

Legend Biotech maintains a drug-free workplace.

  • Qc /ems Analyst

    il y a 1 semaine

    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** The QC/EMS Analyst,...

  • QC Analyst

    il y a 2 semaines

    Gent, Flandre, Belgique Legend Biotech Temps plein

    Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

  • QC Supervisor

    il y a 4 semaines

    Gent, Flandre, Belgique Legend Biotech Temps plein

    Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

  • QC Analyst, East Flanders

    il y a 2 semaines

    Gent, Flandre, Belgique TN Belgium Temps plein

    Voor onze klant in Zwijnaarde zijn we op zoek naar een QC Analyst.Je taken en verantwoordelijkheden omvatten:Verantwoordelijk voor het afronden van QC testen met betrekking tot de productie van autologe producten voor klinische studies en commerciële exploitatie in een gecontroleerde cGMP cleanroom omgeving.Ervoor zorgen dat het testen wordt uitgevoerd in...

  • Junior QC Analyst

    il y a 2 semaines

    Gent, Flandre, Belgique Legend Biotech Temps plein

    Are you ready to make a meaningful impact on patients' lives, embrace challenges and grow beyond your dreams? Then we invite you to embark on a journey to become a Legend in your own right. Join our vibrant Quality Operations Team and experience how far your passion for quality can take you. As a QC Analyst in CAR-T Manufacturing, you are a vital contributor...

  • QC Support Technician

    il y a 4 semaines

    Gent, Flandre, Belgique Legend Biotech Temps plein

    Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

  • YOUNG GRADUATES

    il y a 2 semaines

    Gent, Flandre, Belgique TN Belgium Temps plein

    Social network you want to login/join with:Client:Start PeopleLocation:Job Category:OtherEU work permit required:YesJob Reference:af97a9f67078Job Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:For our client in Zwijnaarde, we are looking for a QC Analyst.Your tasks and responsibilities include:Responsible for the completion of QC testing...

  • Group Leader Analytical Sciences

    il y a 1 semaine

    Gent, Belgique Ardena Temps plein

    **About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...

  • Group Leader Analytical Development Large Molecules

    il y a 2 semaines

    Gent, Belgique Ardena Temps plein

    **About us** **_ Ardena_** _is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...