Context
As part of the development of its activities, the Global Industrial Development department is recruiting an Industrial Development Project Manager (M/F). You will play a central role in the industrial transfer of strategic projects, particularly for new products and technology transfers, ensuring a smooth transition between development and commercial production phases.
Missions
Industrialization project management:
- Define and lead the industrialization strategy.
- Contribute to process selection (Quality by Design approach).
- Coordinate R&D and industrial teams.
- Write protocols and reports for process optimization and validation.
- Monitor batch manufacturing in compliance with GMP and analyze results.
- Ensure product compliance, cost and timeline adherence, and integration of technical and regulatory updates.
Technical support to the production site:
- Participate in supplier and process change validations.
- Actively contribute to troubleshooting related to production processes.
- Supervise galenic/industrial trials and risk analyses (FMEA).
Department activities:
- Contribute to drafting procedures, audits, inspections, and documentation follow-up.
Your profile :
Profile
- Engineer or pharmacist with at least 3 years of experience in the pharmaceutical industry in roles related to production systems.
- Essential biotechnology skills: USP/DSP, DNA/RNA biomolecules, GMP applied to bioprocesses, single-use systems, aseptic processes, scale-up/scale-down.
- Experience in project management and team coordination.
- Knowledge of injectable processes and the associated regulatory framework.
- Assets: Quality by Design, statistical tools (Minitab).
- Fluent in English and French; occasional availability for shift work and travel.
