Expert Quality Control Method (M/F)

Promethera Biosciences is a global innovator in liver therapeutics whose mission is to enable patients to overcome acute and chronic liver diseases. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.

If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 60 people, consider a collaboration with our fast-growing company. Promethera Biosciences is currently hiring an Expert Quality Control Method.

The selected candidate will have the following responsibilities:

MAIN RESPONSIBILITIES

  • Bring knowledge and broad vision to the quality department in terms of analytical methods
  • Ensure technological watch/technology intelligence and inform colleagues of potential new/improved methods
  • Analyze and review current quality assays performed at Promethera with the aim of improving it
  • Establish and maintain contact with R&D department and ensure that methods under development are adequate for (future) GMP testing GMP (conformance with ICHQ2 guidelines)
  • Ensure adequate and efficient technology transfer between R&D/third parties and QC department
  • Prepare assay validation protocols, supervise assay validation and generate validation reports
  • Establish contract with quality control subcontractors for new method development
  • In the case of outsourced QC method validation, ensure follow-up and reporting
  • Participate to QC related out of specification and/or deviation investigation
  • Support the QC department in trouble shooting

QUALIFICATIONS

  • Master or Ph.D. degree in sciences or demonstrated relevant experience
  • Minimum 5-8 years in the biopharmaceutical industry or academic research
  • Experience with cell culture and cell-based assays: Flow cytometry, QPCR, ELISA, ICC, Spectrophotometry, cell staining, cell morphology, tumorigenicity, karyotyping, …
  • Experience with cell therapy (stem cells, progenitor cells, primary cells, …) is a must
  • Curiosity and creativity
  • Quality minded, autonomous, rigorous and pro-active
  • Demonstrated teamwork and teaching skills
  • Excellent communicator
  • Excellent knowledge of French and English (Written and oral)
  • Mastery of Microsoft office tools, more particularly Word and Excel, is mandatory. Microsoft Project is a plus

LOCATION

  • At our headquarters in Mont-Saint-Guibert  / Gosselies, Belgium

You may apply for this position by sending your CV and application letter to HR@promethera.com

Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.

 

For information, resumes and application letters received will be retained as long as the employment’s offer is valid and will be destroyed as soon as the position is filled. We will contact you in case we wish to keep your CV after the recruitment period.

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