Grow with us - Your Responsibilities:

• Follow-up and supervision of GMP sponsored projects according to the specifications and schedule described in the quotations:
  • Process Transfer & Scale Up
  • Planning of manufacturing steps and writing of manufacturing documents
  • Take an active part in clean room activities, with specific supervision of GMP productions / manufacturing performed by lab technicians:
    • Buffers and media preparation and inter-campaign activities (CIP, line clearance, environmental controls …),
    • Cell banking
    • Fermentation, cell lysis and extraction methods,
    • Purification by chromatography and tangential flow filtrations,
    • Product formulation, final filtration, storage and shipping.
  • Compilation and review of executed Batch Records,
• Participation in the GMP storage management and ordering of raw materials, reagents, disposables, and follow-up for customers billing operations.
• Ensure continuous improvement and participation to Quality Management System activities such as: 
  • Participation to audits,
  • Writing of Standard Operating Procedure,
  • Deviation, risk analysis, root cause investigation, change control, CAPA follow up,
  • Internal project.
• Communicates with project coordinator & sponsor.
• Understands and follows methods for process qualification and validation.
• Critically analyzes complex data, interprets, and integrates experimental result.
• Collaborates with other members of the team, or department, to develop processes and manufacturing systems.

What will convince us:

• Bachelor’s or master’s degree (biology, biochemistry, biotechnology, bioengineering…) with at least 5 years’ experience in a GMP activity,
• Significant expertise related to bioprocess development (molecular biology, fermentation, purification, quality controls, plasmid production and characterization),
• Good project, people supervision and communication skills,
• Dynamic, determined and solution-oriented,
• Autonomy, ability to solve problems independently in a changing environment, to manage several tasks in parallel and to interact with other departments (team spirit),
• Good verbal and written communication in English.
• Proven software skills, e.g.MS Office