GID Technical Leader

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/87gi5y

Industrial Development Technical leader

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). You will play a central role in the industrial transfer of strategic projects, particularly for new products and technology transfers, being responsible for implementing and overseeing the technical aspects of product manufacturing from the I&D; development phase through industrial launch, site transfers, and change control implementation.

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,

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/87gi5y