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Masterand (m/w/d) QA Operations

Daiichi Sankyo Co., Ltd.
  • US
    New Bremen, Ohio, United States
  • US
    New Bremen, Ohio, United States

Über

Title Assessment of Stakeholders and Concepts Involved in Establishing a New Manufacturing Site
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 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 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.
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  • New Bremen, Ohio, United States

Sprachkenntnisse

  • English
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