Engineer Assistant, Viral vector GMP Production

Paris, France

The selected candidate will work under the supervision of the Head of viral vector production, within the new Cellectis production unit based in Paris, to ensure the production of AAV vector batches (Adeno-Associated Virus, raw material for the production of cell therapy products). Candidate will work in compliance with good manufacturing practices (GMP), environmental, health and safety rules and internal procedures to guarantee the quality of clinical and commercial batches that will be produced.

Your main missions will be:

  • To contribute to the GMP production of AAV batches within the viral vector team
  • To identify and analyze anomalies or deviations and apply corrective actions whenever necessary
  • To prepare batch documentation, consolidate quality controls for the release of AAV batches
  • To monitor maintenance and qualification of AAV production areas, changeovers and cleaning / decontamination between production campaigns
  • To liaise with AAV production team, quality control, quality assurance and maintenance

As part of continuous improvement programs:

  • To plan and perform development studies to implement production processes in GMP environment
  • To contribute to follow-up of relevant projects at CMOs and CROs
  • To ensure creation and update of the documentation associated with new/updated processes
  • To contribute to the training of the team and technical supervision of the R&D laboratory

Published on November 29, 2019

Required skills:

  • Operational experience of Biologic manufacturing in GMP environment
  • Production and purification of viral vectors (USP and DSP)
  • Analytical techniques used for viral vector quality control

 

 

Minimum Requirements :

  • Technical degree/ Bachelor in Biotechnology, Biology, Bioengineering
  • A minimum of 3-5 years of professional experience in a pharmaceutical industry or biotech with regulated manufacturing activities (GMP preferred)
  • Excellent knowledge of technologies, equipment and processes for production of gene therapy products
  • Autonomous, proactive, motivated and agile
  • Enjoys working in teams and in project-like organization 
  • Fluent in English, knowledge of French would be a plus
  • Good knowledge of Microsoft Office (Excel, Powerpoint, Word, …)