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QA/QC responsible- Advisor

Offentlig forvaltning

At the Center for Advanced Cell Therapy (ACT) there is a vacancy for a permanent position as QA/QC responsible/advisor.

ACT is a core facility resource situated at Oslo University Hospital, the Radium hospital, under the Section for Cell Therapy. The primary goal of the ACT center is to facilitate the development of novel advanced therapy medicinal products (ATMP) and make novel therapies available to Norwegian patients. Through a single entry point, ACT will support and guide clients through the required steps from research product to a quality assured product for use in clinical trials. This involves facilitating regulatory issues, process development, process validation, agreements, financing etc.

The QA/QC responsible person will be part of ACT and will support the ATMPs process development and manufacturing within the Unit for Cell Therapy.

Oslo University Hospital is a workplace with very good opportunities for both professionally and personally development. To be able to meet the challenges of today and the future, we need skilled and committed people co-workers. We are a developing workplace that will look after both patients, relatives and employees, and in that way we can live up to our vision; "Together with the patients, we create tomorrow treatment".

Oslo University Hospital is a workplace with great diversity. We believe that is absolutely crucial to solving the tasks required from us. We therefore want this diversity to be reflected among our applicant’s positions and encourage everyone to apply regardless of who you are and what background you have.
 

Kvalifikasjoner:

  • Authorized bioengineer, pharmacist or equivalent relevant education
  • 3-5 years of relevant education, preferably with professional expertise in laboratory work
  • Experience from quality control work within the pharmaceutical industry, biotechnology or similar
  • Knowledge/experience with GMP work and quality systems
  • Competence and experience within microbiological analyses
  • Good understanding of and experience with relevant analytical equipment instruments and methods
  • Must be fluent in English and Norwegian (or a Scandinavian language) in writing and orally

Additional merits

  • Experience with process development for ATMPs within a regulatory framework for EU clinical trial
  • Experience with writing IMPD for ATMP, preferably for cell therapy
  • Experience with automated and closed system for cell separation, genetic modification, expansion and harvesting
  • Experience with viral vector production in pre-GMP or GMP environment
  • Experience working in core facilities 

Personlige egenskaper:

With us, it is important that you:

  • have the ability to collaborate across different professional groups
  • can work independently
  • can work in a targeted, structured and solution-oriented manner
  • have good analytical skills

Vi tilbyr:

  • A safe workplace with good colleague support
  • Good opportunities for professional and personal development
  • As a new employee in OUS, you become part of a new employee program
  • Salary by agreement within OUS's collective agreements