(Sr.) CMC Manager Devices

We are looking for a (Sr.) CMC Manager Devices to support all clinical projects with respect to production of Leyden Labs products, product quality, and CMC documentation for regulatory dossiers. The ideal candidate has an understanding of the design, development, and lifecycle management of medical devices and drug-device combinations, thorough knowledge of the regulatory device requirements, and working experience in CMC/GMP project management for the management of CMO’s and suppliers.

Requirements

• PhD or equivalent degree in Engineering, Life Science or related field
• Minimum of 5 years of significant CMC experience in the (bio)pharmaceutical industry with a focus on medical devices and drug-device combinations
• Good knowledge of GMP and CMC considerations related to the manufacture of (bio)pharmaceutical products
• Understanding of development and life cycle management of drug-device combinations
• Experience in collaboration with external vendors and subcontractors
• Very good communication skills including excellent command of English

Benefits

• Remote or hybrid working