Tech Management Lead

vor 4 Wochen

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

About Daiichi Sankyo Europe

Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.

Job Title: Tech Management Lead (m/f/x) Drug Substance

We are seeking a highly qualified Tech Management Lead to join our team in Pfaffenhofen/Ilm. As a key member of our Site Launch Team, you will be responsible for the management of technology transfer of the manufacturing processes of drug substance, including Antibody-Drug Conjugates, for investigational and commercial drugs.

Key Responsibilities:

  • Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects
  • Act as main interface to internal and external sites
  • Review technical documentation associated with manufacturing, tech transfer, site-to-site transfers, and PPQ as needed
  • Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. Drug Substance perspective
  • Communicate and implement manufacturing plans at the site aligned with cross-functional CMC strategic discussions
  • Communicate outcome of key meetings to stakeholders and functional areas
  • Support technical recommendations for future sites and their selections
  • Collect and share key data from KPI perspective to improve drug substance manufacturing site performance
  • Conduct data review and analysis, data-driven decision-making process, and support data transfer to the appropriate data repository - liaison between the Tech Strategy (data digitalization) and the site
  • Recommend remediations, CAPAs, and provide inspection support as appropriate to mitigate risks or gaps
  • Participate in the CMC working group meetings and communicate clear, timely, and detailed updates on tech transfers and site activities
  • Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books
  • Coordinate with lab units, SC, RACMC, QA to drive collaboration and solve issues in Tech Mgmt. Drug Substance team

Requirements:

  • Ph.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master's degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences
  • At least 4 years of experience or more in the pharmaceutical/biotechnology industry working in a process development environment
  • Extensive experience in CMC related functions, including biopharmaceutical process (preferably drug substance manufacturing) and product development
  • Strong knowledge of CMC development, process development, and technology transfer, CMC regulatory, and GMP compliance in the field of biopharmaceutical drug substances (preferably ADCs)
  • Strong verbal and written communication skills in English and ability to interface effectively with multi-national teams in a multi-cultural work environment
  • Leads global project and cross-functional working teams (e.g., Site Launch Team). Works with the CMC Working Group team to determine the scope, assumptions, and key objectives to enable effective risk management to ensure the timelines are maintained
  • Influences outcomes by negotiating win-win solutions and resolving conflict across the team membership
  • Plans and organizes tasks in accordance with the strategic organizational decisions and goals in alignment with overall Technology Development organization
  • Contributes to operational planning and organization of a key functional process, continually evaluates priorities of actions and tasks required of the process

Why work with us?

Working at Daiichi Sankyo Europe is more than just a job – it is your chance to make a difference and change patients' lives for the better. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

  • Tech Management Lead

    Vor 6 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAt Daiichi Sankyo Europe, we are seeking a highly skilled Tech Management Lead - Drug Substance to join our team. As a key member of our organization, you will be responsible for managing technology transfer of manufacturing processes for drug substance, particularly Antibody-Drug Conjugates, to internal and...

  • Tech Management Lead

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 1 Monat

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Tech Management Lead

    vor 1 Monat

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...

  • Team Lead CMO Management QA

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Team Lead CMO Management QAAt Daiichi Sankyo Europe, we are seeking a highly qualified Team Lead to join our Quality Assurance team. As a Team Lead, you will be responsible for managing a team of quality professionals who oversee the quality of our Contract Manufacturing Organizations (CMOs) in Europe.Key Responsibilities:Manage a team of 4-5...

  • Team Lead CMO Management QA

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Job Title: Team Lead CMO Management QAAt Daiichi Sankyo Europe, we are seeking a highly qualified Team Lead to join our Quality Assurance team. As a Team Lead, you will be responsible for managing a team of quality professionals who oversee the quality of our Contract Manufacturing Organizations (CMOs) in Europe.Key Responsibilities:Manage a team of 4-5...

  • Procurement Team Lead

    vor 1 Monat

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job SummaryWe are seeking a highly skilled Procurement...

  • Procurement Team Lead

    vor 1 Monat

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job SummaryWe are seeking a highly skilled Procurement...

  • Procurement Leader

    vor 3 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.Job Title: Lead Buyer...

  • Procurement Leader

    vor 3 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.Job Title: Lead Buyer...

  • Procurement Leader

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.Job Title: Lead Buyer...

  • Procurement Leader

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.Job Title: Lead Buyer...

  • Procurement Team Lead

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.Job SummaryWe are seeking a highly skilled...

  • Procurement Team Lead

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.Job SummaryWe are seeking a highly skilled...

  • Procurement Team Lead

    Vor 7 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.Job SummaryWe are seeking a highly skilled...