Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz-Kreislauf-Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.
Title
Assessment of Stakeholders and Concepts Involved in Establishing a New Manufacturing SiteBackground:Daiichi Sankyo Europe GmbH (DSE) is planning to build a greenfield Biological Drug Substance (DS) Production Facility. This ambitious project requires a well-defined responsibility landscape, particularly focusing on quality assurance and technology transfer perspectives, to ensure smooth and compliant site establishment.Objective:The Master's thesis aims to assess the stakeholders and key concepts involved in establishing a new manufacturing site. The focus will be on defining and mapping responsibilities from a quality and transfer perspective.
Background:
Daiichi Sankyo Europe GmbH (DSE) is planning to build a greenfield Biological Drug Substance (DS) Production Facility. This ambitious project requires a well-defined responsibility landscape, particularly focusing on quality assurance and technology transfer perspectives, to ensure smooth and compliant site establishment.
Objective:
The Master’s thesis aims to assess the stakeholders and key concepts involved in establishing a new manufacturing site. The focus will be on defining and mapping responsibilities from a quality and transfer perspective.
Timeframe:
- Expected duration- 6 months
- Start 01.09.2026 or later possible
Scope and Approach:
- Provide a general overview of the stakeholder ecosystem and conceptual frameworks involved in manufacturing site establishment.
- Conduct a deep dive into 1-2 critical areas (e.g., contamination control strategy or process risk assessment) to analyze roles, responsibilities, and workflows in detail.
- Formulate conclusions, identify learnings, and propose improvements to optimize responsibility allocation and transfer processes.
Expected Outcomes:
- A comprehensive responsibility matrix illustrating stakeholder roles and interrelations from quality and transfer perspectives.
- Recommendations for process enhancements and frameworks to support efficient site establishment and operational readiness.
Your Profile:
- Enrollment in a Master’s program in Pharmaceutical Sciences, Biotechnology, Biology, Bioengineering, or a related discipline.Strong analytical, research, and communication skills in English.Interest in pharmaceutical manufacturing, quality systems, and project management.Prior knowledge of GMP
- Enrollment in a Master’s program in Pharmaceutical Sciences, Biotechnology, Biology, Bioengineering, or a related discipline.
- Strong analytical, research, and communication skills in English.
- Interest in pharmaceutical manufacturing, quality systems, and project management.
- Prior knowledge of GMP processes or pharmaceutical industry is a plus but not mandatory.
What We Offer:
- Hands-on experience with a strategic manufacturing project at a leading global pharmaceutical company.
- Mentorship from experts in quality assurance and technology transfer and support from a multidisciplinary team.
- Opportunity to contribute to the successful launch of a key production facility.
