RIF. 3790: DIRECTOR OF MANUFACTURING OPERATIONS & PROCESS INDUSTRIALIZATION

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