Leiter der Herstellung (m/w/d)
Core
Lead manufacturing operations for a biopharmaceutical company producing cell transplants for joint cartilage repair.
Role type
Senior manufacturing operations manager (biopharma)
Builds
Cell therapy products for orthopedic cartilage repair
Domain
Biopharmaceuticals / Cell therapy
Required skills
GMP compliance, regulatory affairs, deviation management, budget management, team leadership, process optimization
Preferred skills
FDA experience, Annex 1 and Annex 4 knowledge, project management
Technologies
GMP systems, error prevention systems
Responsibilities
Organize and monitor manufacturing department, ensure GMP and regulatory compliance, manage deviations, prepare for inspections, collaborate with QC/QA/Engineering, manage budget, lead ~20 employees, handle HR tasks
Seniority
Senior, hands-on IC with people management