Context
As part of the development of its activities, the Global Industrial Development department is recruiting an Industrial Development Project Manager (M/F) based in Porto Empedocle's plant (Italy).
Industrial Development Technical leader
As part of the development of its activities, the Global Industrial Development department is recruiting an Industrial Development Project Manager (M/F) based in Porto Empedocle's plant (Italy).
Missions
Industrialization Project Management
- Define and lead the industrialization strategy
- Contribute to process selection (Quality by Design approach)
- Coordinate I&D; and industrial teams (production, purchasing, quality assurance, quality control, maintenance)
- Write risk analysis, protocols and reports for process optimization and validation, and review master batch record accordingly
- Monitor batch manufacturing in compliance with GMP and analyze results
- Ensure product compliance, EHS rules, projects cost and timeline adherence, 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
- Master's degree (MSc, Engineering Degree, or equivalent) in biology, chemistry or pharmacy with at least 5 years of experience in the pharmaceutical industry in roles related to production systems.
- GMP rules
- Experience in project management and team coordination and/or transversal management
- Knowledge of injectable processes and the associated regulatory framework.
- Assets: Quality by Design, statistical tools (Minitab)
- Fluent in English, occasional availability for shift work and travel.
About The Job
- Type of contract: tempo pieno - permanent
- Location: Porto Empedocle (AG) - Italy
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