Dr. Bernhard Unterlinner
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Bernhard Unterlinner
- Bis heute 6 Jahre und 5 Monate, seit 2019
Interim management and support: (bio)pharmaceuticals, medical devices
Selbständig
• Project Management • Quality Management (GMP, GDP, GCP, GPV) • Manufacturing (steriles, non-steriles, biopharmaceuticals) • Qualified Person (QP, QPPV) • Process optimization (manufacturing, quality, supply chain) • Inspection readiness and audits • Support for granting of permissions (manufacturing, wholesale, controlled drugs) • Operative support (CAPAs, changes, systems upgrade, CMC, PQRs) • Validation and qualification
- 2017 - 2019
Head Quality and Third Party Management
Klinge Pharma
- Establishment and maintenance of a state-of-the-art operational-, manufacturing-, quality-, supply- and pharmacovigilance-system for a newly founded pharmaceutical company - Preparation and successful application for GMP- and GDP-certificates and licences - Project lead for IT-system launches and lean operational processes - Implementation of international business expansion - Management of interfaces to international CDMOs (USA, Europe, Asia), business development and sales units
- 2016 - 2016
Global Head Quality: Biopharmaceutical Processes
Sandoz/Novartis
- Alignment within Novartis: harmonization and enhancement of global business processes for biopharmaceuticals - Integration of quality systems for biopharmaceuticals - Governance of effectiveness of business process standardization
- 2011 - 2015
Direktor Operations
Fresenius-Kabi
- Deputy site head - Head of production units and quality management representative - Key contact for business development
- 2008 - 2010
Quality Assurance
Contract manufacturer
Leitung der Qualitätssicherung des Standortes
- 2002 - 2008
Qualified Person und Head of CMC Dokumentation
Fujisawa bzw Astellas Pharma
Head of Product Release and CMC-Documentation - Qualified Person
- 1999 - 2002
Quality Assurance
Hoffmann-La Roche
Quality Assurance Marketed Products - Head of Quality Assurance Rocephine Focus Factory
Ausbildung von Bernhard Unterlinner
- 1995 - 1999
Genetik
LMU München
- 1990 - 1995
Pharmazie
LMU München - Purdue University IN/USA
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
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