Rif. 3790: Director Of Manufacturing Operations & Process Industrialization
Descrizione dell'offerta
RIF. 3790: DIRECTOR OF MANUFACTURING OPERATIONS & PROCESS INDUSTRIALIZATION
Position Overview
For our Client, a biotech company, we are seeking an experienced Director of Manufacturing Operations & Process Industrialization to lead the industrialization, production, and supply chain operations for its bioengineered medical device platform.
The role will lead the industrialization and scale-up of our Client's bioengineered manufacturing processes as the company transitions from laboratory-scale production to regulated commercial manufacturing. The role will focus on developing robust, scalable, and validated manufacturing processes capable of supporting U.S. commercial operations and international scale.
Reporting to the Chief Technology Officer, the Director of Manufacturing Operations & Process Industrialization will oversee three core operational domains:
- Process Industrialization & Scale-Up
- Manufacturing Operations
- Supply Chain & Production Readiness
The role requires strong experience in regulated medical device manufacturing environments (FDA/MDR), and the ability to scale production processes while maintaining compliance, traceability, and operational efficiency.
The Director will lead dedicated teams across these domains and will play a key role in ensuring manufacturing readiness, capacity planning, and supply reliability as the company expands its product portfolio.
The ideal candidate has first-hand experience translating a development-stage biomaterials process into a robust, validated manufacturing process capable of supporting regulatory submission and early commercial production.
Qualifications & Experience
Required:
- 10+ years of experience in medical device manufacturing or regulated life sciences manufacturing
- Proven experience leading manufacturing operations and industrial scale-up
- Demonstrated experience transitioning a manufacturing process from development or pilot scale into validated commercial production.
- Strong knowledge of FDA QMS / 21 CFR 820 (or QMSR alignment) and ISO 13485
- Experience with process validation (IQ/OQ/PQ) and manufacturing qualification
- Demonstrated ability to manage multi-disciplinary teams
- Experience managing supply chain and supplier quality in regulated environments
- Strong understanding of traceability, batch records, and manufacturing documentation
- Excellent leadership and communication skills
- Fluency in English
Preferred:
- Experience with biomaterials manufacturing, or advanced textile-based medical technologies
- Experience supporting FDA submissions or U.S. market entry
- Experience building manufacturing teams and processes from early-stage to commercial production
Location : Milan Area