Experteer Overview In this role you will lead the industrialization, production, and supply‐chain efforts for a bio‐engineered medical device platform. You will drive the transition from lab‐scale processes to regulated commercial manufacturing, delivering robust and scalable processes for U.S. and international operations. Reporting to the CTO, you'll oversee process industrialization, manufacturing operations, and supply readiness to ensure capacity, traceability, and compliance. This is a chance to shape manufacturing readiness and scale in a regulated environment with a focus on impact and cross‐functional collaboration.
Retribuzione / Benefits Lead industrialization and scale‐up of manufacturing processes
Oversee three domains: process industrialization, manufacturing operations, and supply chain readiness
Ensure manufacturing readiness, capacity planning, and supply reliability
Manage multi‐disciplinary teams across regulated environments
Maintain traceability,



batch records, and manufacturing documentation
Support regulatory submissions and compliance with FDA/QMS standards
Responsabilità 10+ years in medical device or regulated life sciences manufacturing
Proven experience leading manufacturing operations and industrial scale‐up
Experience transitioning processes from development/pilot to validated commercial production
Strong knowledge of FDA QMS / 21CFR820 (or QMSR) and ISO13485
Experience with process validation (IQ/OQ/PQ) and manufacturing qualification
Ability to manage multi‐disciplinary teams and oversee supply chain in regulated settings
Experience with traceability, batch records, and manufacturing documentation
Excellent leadership and communication skills
Fluency in English
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📌 RIF. 3790: DIRECTOR OF MANUFACTURING OPERATIONS (Italia)
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📍 Italia