Head of Manufacturing Sciences (m/w/d)
Core
Leading Manufacturing Sciences for solid oral dosage forms at the Oranienburg site, ensuring GMP compliance, technology transfer, and scale-up for commercial production.
Role type
Head of Manufacturing Sciences (Site Leadership)
Builds
Solid oral dosage form products (capsules/tablets) for global markets
Domain
Pharmaceutical manufacturing / Solid dosage forms
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations (EU/FDA), technology transfer, process validation, statistical methods (DoE, SPC), regulatory strategy, CMC dossier content, root cause analysis, cross-functional team leadership, project management
Preferred skills
PhD in Pharmacy/Chemical Engineering, experience in process development, PAT initiatives, digitalization and automation in manufacturing
Technologies
GMP Small Scale Plant, PAT (Process Analytical Technology), DoE, SPC
Responsibilities
Lead and develop the Manufacturing Sciences team; Ensure GMP compliance and regulatory strategy alignment; Drive technology transfer and scale-up projects; Collaborate with global Manufacturing Sciences and Pharmaceutical Sciences functions; Support operational excellence and digitalization initiatives; Lead troubleshooting and root cause analysis for production issues.
Seniority
Senior, Site Leadership