Quality Control Engineer

CellProthera is a biotech company based in Mulhouse (FR) developing innovative cell therapy products based on a proprietary cell processing technology platform. A multi-center Phase I/IIb clinical trial is currently on-going in Europe to test the therapy product Protheracytes®  (ATMP) in patients having suffered from severe acute myocardial infarction.

Your mission

Under supervision of the Director of Quality and Regulatory Affairs and in close collaboration with the Quality Assurance team, you are actively working at the development of standards, methods and procedures for inspecting, testing and assessing the accuracy, efficacy and reliability of our stem cell based process and product:

  • Develop test protocols to characterise and identify stability of key elements of the processes and cell therapeutic product
  • Write, set-up and follow-up new QC tests with external laboratories
  • Compile data for documentation of test procedures and prepare reports
  • Write and update Standards Operating Procedures and QMS documentation (deviations/change control/CAPA/OOS) in GMP environment

Your profile 

Skills and experience

  • Degree in Biotechnology, Biology, Pharmacy or equivalent level
  • 3-5 years’ experience in the industry, preferably pharma, biotech or equivalent
  • Experience in Quality Control
  • Familiarity with laboratory techniques and QC test methods
  • English fluent. French conversational is a plus
  • Strong analytical skills

Personal characteristics

  • Ability to work in autonomy in a demanding regulatory environment
  • Rigorous, dynamic, result-oriented and hands-on hard-worker
  • Well-structured, self-motivated and solutions oriented

 

Applicants should also be entitled to work within the European Economic Area (EEA).

The position is located in Mulhouse, France. If you are interested in this job, please contact Paula Lee (plee@cellprothera.com)