Leitung der Herstellung klinischer Prüfpräparate Parenteralia (all genders) (Vollzeit, unbefristet)
Core
Leading the manufacturing of parenteral clinical trial preparations (vials and syringes) under GMP regulations.
Role type
Senior Manufacturing Team Lead (Parenteral Clinical Trials)
Builds
GMP-compliant parenteral bulkware for clinical studies
Domain
Pharmaceutical manufacturing / Clinical trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, aseptic manufacturing, CAPA management, pharmaceutical quality management, regulatory inspection preparation, project team leadership, investment planning, process validation
Preferred skills
multidisciplinary project collaboration, mentorship, strategic planning
Technologies
GMP guidelines, EU-GMP, AMG, AMWHV
Responsibilities
Plan, execute, and monitor manufacturing of parenteral clinical trial preparations; Review and approve manufacturing documents and deviation reports; Manage CAPA for deviations; Lead aseptic process simulations and contamination control; Participate in regulatory inspections and audits; Contribute to investment planning and new facility commissioning; Lead and develop subordinate staff
Seniority
Senior, hands-on IC with leadership responsibilities