Qc Analyst

il y a 4 semaines


Gent, Belgique International Recruitment Temps plein

**Key Responsibilities**
- Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment
- Ensure testing 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 cGMP facility to manufacture products
- Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
- 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

**Profile**

**Requirements**:

- Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
- Minimum of 1 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required
- 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 skill are required

**Offer**

Company is seeking **QC Analyst **as part of the **Quality **team based in **Ghent.**

**Role Overview**

The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. **There is potential to be converted to a permanent employee after 6 months**.

**Company**

Our client is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, they 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) cell-based immunotherapy.

Our client 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) in 2017. Their 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.

Company maintains a drug-free workplace.


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