Aktuelle Jobs im Zusammenhang mit Senior Director of Drug Substance Operations - Munich, Bayern - Discover International


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeAbout the Role:We are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to execute clinical trials in Europe.Key...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeAbout the Role:We are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to execute clinical trials in Europe.Key...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeWe are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeWe are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeWe are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeWe are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeWe are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Senior Director, Global Clinical Operations EuropeWe are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About the RoleThe Senior Director, Global Clinical Operations Europe, will provide leadership and operational expertise in the execution of Research & Development (R&D) studies conducted in Europe. This role will be part of the Global Clinical Operations (GCO) group in R&D.Key ResponsibilitiesCollaborate with Contract Research Organization (CROs) to...


  • Munich, Bayern, Deutschland Giesecke+Devrient GmbH Vollzeit

    Job Title: Global Director of Security OperationsWe are seeking a highly skilled and experienced Global Director of Security Operations to join our team at Giesecke+Devrient GmbH. As a key member of our organization, you will be responsible for ensuring the efficiency and excellence of our IP Operations capability.Key Responsibilities:Develop and maintain a...


  • Munich, Bayern, Deutschland Giesecke+Devrient GmbH Vollzeit

    Job Title: Global Director of Security OperationsWe are seeking a highly skilled and experienced Global Director of Security Operations to join our team at Giesecke+Devrient GmbH. As a key member of our organization, you will be responsible for ensuring the efficiency and excellence of our IP Operations capability.Key Responsibilities:Develop and maintain a...


  • Munich, Bayern, Deutschland Giesecke+Devrient GmbH Vollzeit

    Join our team at Giesecke+Devrient GmbH as a Global Director of Security Operations. We are seeking a highly skilled and experienced European and/or German Patent Attorney to lead our Global IP Operations team. The ideal candidate will have a strong leadership background, business acumen, and up-to-date knowledge of IP strategies, trends, and practices. Key...


  • Munich, Bayern, Deutschland Giesecke+Devrient GmbH Vollzeit

    Job Title: Global Director of Security OperationsWe are seeking a highly skilled and experienced professional to lead our Global Security Operations team. As a key member of our organization, you will be responsible for ensuring the security and integrity of our operations across the globe.Key Responsibilities:Develop and implement security strategies to...


  • Munich, Bayern, Deutschland Giesecke+Devrient GmbH Vollzeit

    Job Title: Global Director of Security OperationsWe are seeking a highly skilled and experienced professional to lead our Global Security Operations team. As a key member of our organization, you will be responsible for ensuring the security and integrity of our operations across the globe.Key Responsibilities:Develop and implement security strategies to...


  • Munich, Bayern, Deutschland Turner & Townsend Vollzeit

    About the RoleWe are seeking a highly experienced Director to lead our Real Estate business unit in Munich. As a member of our senior management team, you will be responsible for driving growth, profitability, and sustainability through leadership, new business development, client management, and service delivery.This is a unique opportunity for a...


  • Munich, Bayern, Deutschland 1&1 MAIL & MEDIA APPLICATIONS SE Vollzeit

    Join Our Team as a Director of IT InfrastructureWe are seeking an experienced leader to drive the strategy and execution for the development and management of our core data center and networking capabilities. As the Director of IT Infrastructure, you will be responsible for ensuring the robustness, efficiency, and scalability of our infrastructure to meet...


  • Munich, Bayern, Deutschland 1&1 MAIL & MEDIA APPLICATIONS SE Vollzeit

    Join Our Team as a Director of IT InfrastructureWe are seeking an experienced leader to drive the strategy and execution for the development and management of our core data center and networking capabilities. As the Director of IT Infrastructure, you will be responsible for ensuring the robustness, efficiency, and scalability of our infrastructure to meet...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Director Medical Excellence OperationsWe are seeking a highly qualified candidate to fill the position of Director Medical Excellence Operations at Daiichi Sankyo Europe.About the Role:The Director Medical Excellence Operations will be responsible for harmonizing methodologies and processes throughout the entire European Specialty Medical...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Director Medical Excellence OperationsWe are seeking a highly qualified candidate to fill the position of Director Medical Excellence Operations at Daiichi Sankyo Europe.About the Role:The Director Medical Excellence Operations will be responsible for harmonizing methodologies and processes throughout the entire European Specialty Medical...


  • Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Passion for Innovation. Compassion for Patients.Daiichi Sankyo Europe is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: protecting people from cardiovascular disease, the leading cause of death in Europe, and helping patients who suffer from it to...

Senior Director of Drug Substance Operations

vor 2 Monaten


Munich, Bayern, Deutschland Discover International Vollzeit
Job Summary

The Senior Director of Drug Substance Operations will oversee the technology transfer of drug substance manufacturing processes, particularly Antibody-Drug Conjugates, for both investigational and commercial drugs. This role involves managing the Site Launch Team and ensuring smooth transitions from development to routine manufacture, both internally and externally.

Key Responsibilities
  • Lead and coordinate activities for site launches, overseeing teams across internal and external manufacturing sites as well as development projects.
  • Act as the main point of contact between internal teams and external sites, ensuring seamless communication and collaboration.
  • Review and manage technical documents related to manufacturing processes, technology transfers, site transfers, and PPQ.
  • Scout and recommend Contract Development and Manufacturing Organizations (CDMOs) for clinical trials and launch site selection based on project needs.
  • Communicate and implement manufacturing plans, ensuring alignment with cross-functional Chemistry, Manufacturing, and Control (CMC) strategies.
  • Ensure key outcomes from meetings are effectively communicated to stakeholders and relevant functional areas.
  • Provide technical recommendations for future manufacturing site selections and improvements.
  • Gather and analyze data to drive performance improvements at drug substance manufacturing sites.
  • Manage data review, analysis, and transfer, serving as a liaison between Technical Strategy and the manufacturing site.
  • Recommend risk mitigation strategies, including Corrective and Preventive Actions (CAPAs), and offer inspection support as needed.
  • Participate in CMC working group meetings, providing timely updates on technology transfers and site activities.
  • Assist with compiling and reviewing CMC sections of regulatory submissions and responses to regulatory inquiries.
  • Coordinate with laboratory units, supply chain, Regulatory Affairs and Compliance Management (RACMC), and Quality Assurance (QA) to foster collaboration and resolve issues within the Drug Substance team.
Requirements
  • Educational Background: Relevant degree within life science
  • Industry Experience: Minimum of 5 years in the pharmaceutical/biotechnology industry,
  • Modalities: Must have experience in ADC & Bioconjugation / This is crucial
  • Communication Skills: Excellent verbal and written communication skills in English, with the ability to work effectively in a multi-national, multi-cultural environment.
  • Leadership and Teamwork: Experience leading global projects and cross-functional teams, negotiating solutions, resolving conflicts, and aligning tasks with strategic organizational goals.
  • Operational Planning: Ability to contribute to operational planning, evaluate action priorities, and manage key functional processes.
About Discover International

Discover International is a leading biotechnology company dedicated to developing innovative solutions for the pharmaceutical industry. We are committed to excellence in drug substance manufacturing and are seeking a highly skilled professional to join our team as Senior Director of Drug Substance Operations.