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Daiichi Sankyo Company,Limited

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  • Expert (m/w/d) Quality Systems

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Expert (m/w/d) Quality Systems Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position: Expert (m/w/d) Quality Systems Roles and Responsibilities Serve as Regional Administrator for electronic quality management tools like document management system and training management system Perform first level support for all users of Regional electronic quality management tools Support Regional Process Leads und Process Owners in continuous monitoring of process performance and process optimization projects Deputy Regional Process Leads and Process Owners in Regional meetings and projects Support implementation of best practice standards and ensure compliance with quality and regulatory requirements Support document and training material creation Support migration and testing activities for computerized systems Personal skills and professional experience: Completed

  • Medical Science Liaison, Early Development/Hematology - Delaware Valley

    Work Model Remote (Daiichi Sankyo US) | Job Location (Country/Region)

    remote $151K-$226K

    Medical Science Liaison, Early Development/Hematology - Delaware Valley Work Model Remote (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: DE, MD, PA, NJ. Responsibilities Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing

  • Senior Specialist Accounting (m/f/d)

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Senior Specialist Accounting (m/f/d) Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function LOCATION: MUNICH, GERMANY Perform and partly coordinate all Accounting activities in the defined regional scope in the GBS ESC to ensure the performance of Accounting services in high quality as well as in a timely and fully compliant manner. Support and partly coordinate building up and stabilizing the new organizational set-up of the GBS ESC and the new end-to-end (E2E) processes in the defined regional scope of the GBS ESC. Closely collaborate and partly coordinate within the service line teams and support other GBS ESC service line teams as aligned with the responsible line manager, help to ensure that all interfaces are fully covered Roles and Responsibilities Operate and partly coordinate all Accounting-related transactions in sub ledgers and Cash Operations, especially related to Order-to-Cash (O2C), Procure-to-Pay (P2P), Bank Accounting and Master Data Management considering relevant Accounti

  • Manager, Statistical Programming (m/f)d)

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Manager, Statistical Programming (m/f)d) Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. The Position The purpose of this role is to lead and contribute to statistical programming activities across SDTM, ADaM, and Tables, Listings, and Figures (TLFs), providing both technical oversight and hands-on support for the development, validation, and programmatic review of datasets and outputs. This role ensures the quality, consistency, and timeliness of deliverables supporting oncology regulatory submissions by guiding programming strategies, reviewing key outputs, and driving issue resolution. In addition, this position fosters and maintains institutional knowledge across oncology compounds, while supporting the development, standardization, and continuous improvement of programming processes and best practices for datasets and TLFs to enhance efficiency, quality, and compliance. Roles and Responsibilities Lead and Execute Statistical Programming Develop and validate datasets and Tables, Listings, and Figures (TLFs)

  • Ausbildung zum Chemielaboranten (m/w/d) Ausbildungsjahr 2027

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Ausbildung zum Chemielaboranten (m/w/d) Ausbildungsjahr 2027 Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Als entwickelndes und produzierendes Pharmaunternehmen suchen wir motivierte und engagierte Nachwuchskräfte, die uns im Laborbereich unterstützen. Während Deiner Ausbildung erwirbst Du die notwendigen Kenntnisse zur Durchführung von chemischen und physikalischen Analysen, im Rahmen der analytischen Kontrolle von Arzneimitteln und deren Rohstoffe. Zum 01.09.2027 suchen wir Dich für die 3,5-jährige Ausbildung als Chemielaborant/in an unserem Standort in Pfaffenhofen an der Ilm. Die Berufsschule befindet sich in München und findet im Blockunterricht statt (https://bs-zt-chem.musin.de/). Das bringst Du mit: Gute mittlere Reife oder höherer Schulabschluss mit guten Leistungen in Chemie und Mathematik Interesse an naturwissenschaftlichen und technischen Fragestellungen Fingerfertigkeit, manuelles Geschick Hohes Verantwortungsbewusstsein (z.B. für die Einhaltung von Sicherheitsregeln und Umweltbestimmungen) Flexibili

  • Teamleiter (m/w/d) Technik Verpackung

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Teamleiter (m/w/d) Technik Verpackung Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Angaben zur Tätigkeit In dieser verantwortungsvollen Position stellen Sie die technische Betriebsbereitschaft unserer Verpackungslinien sowie der zugehörigen Nebeneinrichtungen sicher und treiben deren kontinuierliche Verbesserung voran. Disziplinarische und fachliche Führung der Experts Packaging sowie fachliche Führung der Mechaniker Sicherstellung der technischen Verfügbarkeit und Optimierung der Anlagen im Bereich Verpackung Gewährleistung einer termin-, mengen-, qualitäts- und kostenoptimalen Produktion Verantwortung für die Einhaltung und Umsetzung von GMP-Richtlinien Planung, Koordination und Durchführung von Instandhaltungsmaßnahmen (intern und extern) Verantwortung für das Ersatzteilmanagement Initiierung, Mitwirkung und ggf. Leitung von technischen Verbesserungsprojekten Anwendung und Weiterentwicklung von Methoden der kontinuierlichen Verbesserung (KVP) Umsetzung von Optimierungsmaßnahmen unter technischen, wirts

  • Director, Regulatory Affairs Advertising and Promotion

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Director, Regulatory Affairs Advertising and Promotion Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Reporting to the Head of RAAP, this role serves as a senior regulatory advertising and promotion subject matter expert and is accountable for guiding compliant, effective communications in alignment with FDA regulations, guidance, enforcement trends, approved labeling, internal standards, and business objectives. The Director is responsible for leading regulatory strategy and decision-making for complex, high-risk, high-visibility, or precedent-setting advertising and promotion matters. This role serves as a senior advisor to cross-functional stakeholders, plays a significant role in labe

  • Fachinformatiker für Systemintegration (m/w/d) für den Bereich Quality Control

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Fachinformatiker für Systemintegration (m/w/d) für den Bereich Quality Control Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Zum nächstmöglichen Zeitpunkt suchen wir für unseren Standort in Pfaffenhofen an der Ilm eine/n engagierte/n Fachinformatiker für Systemintegration (m/w/d) für den Bereich Quality Control Als Teil unseres Teams QC-EDP (Data Management & Systems) begleitest du maßgeblich IT-Projekte im Pharma-Bereich Quality Control. Angaben zur Tätigkeit: Planen, installieren, qualifizieren und administrieren von IT-Systemen im Laborbereich Konfiguration von Netzwerken Administration von Datenbanken wie SQL und Oracle Erstellung von Berechtigungskonzepten und Vergabe von Zugriffsrechten Erstellung und Weiterentwicklung von SharePoint-Lösungen basierend auf der Microsoft Power Plattform Teamsites Sicherstellung der Einhaltung von GMP-Anforderungen und weiteren regulatorischen Vorgaben mit Fokus auf Lifecycledokumentation Mitwirken bei der Konzeptionierung von Active Directory Mitarbeit an Digitalisierungsprojekten Einweisung un

  • Associate Director, Clinical Database Applications and Reporting

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Associate Director, Clinical Database Applications and Reporting Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Summary The Associate Director, Clinical Database Applications and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert responsible for setting the overall programming strategy including the oversight, guidance, implementation, and management of clinical database applications and reporting. The responsibilities include advancing operational excellence by standardizing reporting, scaling programming strategies, automating workflows, and delivering high-quality outputs that meet user requirements by collaborating with variety of internal and external stakeholders including leading all aspects of end-to-end programming efforts. In addition managing quality of data validation programming deliverables; maintaining compliance and inspection readiness of clinical applications, reports, and supporting process documentation; and reporting process are some of the key re

  • Betriebsingenieur mit Fokus Inbetriebnahme (m/w/d)

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Betriebsingenieur mit Fokus Inbetriebnahme (m/w/d) Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Ab sofort suchen wir für unseren Standort in Pfaffenhofen eine/n engagierte/n Betriebsingenieur mit Fokus auf Inbetriebnahme (HKLS) Ihre Aufgaben Haupttätigkeiten: Planung, Steuerung und Durchführung der Inbetriebnahme- und Übergabeaktivitäten Sie verantworten die erfolgreiche Inbetriebnahme von HKLS-Anlagen (Heizung, Klima, Lüftung, Sanitär) inklusive der zugehörigen Gebäudeautomation im Rahmen unserer spannenden Neubauprojekte am Standort Pfaffenhofen. Koordination der Gewerke und Schnittstellen Während der Start-Up-Phase sind Sie zentrale Schnittstelle und koordinieren alle relevanten Gewerke sowie die Zusammenarbeit mit internen Teams, externen Dienstleistern und Lieferanten. Technische Abnahmen und Funktionsprüfungen Sie definieren und führen technische Abnahmen, Funktionsprüfungen und Tests durch, um die Betriebsbereitschaft sicherzustellen und die Einhaltung aller Qualitäts-, Sicherheits- und gesetzlichen Anforderung

  • Manager (m/f/d) Consolidation

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Manager (m/f/d) Consolidation Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Join us at the forefront of innovation at Daiichi Sankyo's newly established European & Canadian Service Center (GBS ESC) as part of the Daiichi Sankyo Global Business Services (DS GloBuS), strategically located in the dynamic cities of Munich and Lisbon. We are on the lookout for highly motivated, experienced and talented individuals to become part of our pioneering and fast-growing team. This is a unique opportunity to contribute to a global enterprise, where your skills and expertise will drive excellence, efficiency and innovation across international operations. Embrace the challenge and be a part of a collaborative, forward-thinking environment, where your career can flourish and where you can shape the future of Daiichi Sankyo and contribute to our mission to improve healthcare worldwide. For our headquarters in Munich we are seeking highly qualified candidates to fill the position: Manager (m/f/d) Consolidation Purp

  • Senior Director, Clinical Safety MD

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Senior Director, Clinical Safety MD Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Sr. Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization). Job Description Responsibilities Dependin

  • Senior Manager (m/w/d) Production Excellence & Operational Support

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Senior Manager (m/w/d) Production Excellence & Operational Support Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Verantwortlich fuer die Steuerung und Weiterentwicklung von Validierungs- und Qualifizierungsstrategien im Produktionsumfeld, die uebergreifende Unterstuetzung der Betriebsabteilungen sowie die Fuehrung komplexer, bereichsuebergreifender GMP-Themen und Projekte mit massgeblichem Einfluss auf Compliance, Inspektionsfaehigkeit und die nachhaltige Optimierung von Produktionsstandards. Angaben zur Tätigkeit: Selbstständige Planung, Steuerung und Verantwortung von komplexen Validierungsprojekten im Produktionsumfeld (Herstell- und Reinigungsprozesse sowie aseptische Produktionsverfahren) Gesamtverantwortung für Qualifizierungsstrategien (PQs) und deren Umsetzung Konzeptionelle Mitgestaltung von Anlagen, Technologien und Investitionen Selbstständige Vertretung der Produktion bei Produkttransfers im Rahmen von Site-Launch-Teams Verantwortung für die Bearbeitung komplexer Abweichungen inkl. systemischer Ursachenanalys

  • Werkstudent Quality Operations (m/w/d) - Bereich Packaging

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Werkstudent Quality Operations (m/w/d) - Bereich Packaging Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Wir suchen ab sofort für unseren Entwicklungs- und Produktionsstandort in Pfaffenhofen/Ilm eine/n engagierte/n Werkstudent Quality Operations (m/w/d) - Bereich Packaging Sie unterstützen dabei unsere QA-Administrator/-innen vor Ort in der Verpackung bei ihren Routinetätigkeiten zur Kontrolle und Verwaltung der QA-seitigen Überwachung der Verpackungsdokumentation. Angaben zur Tätigkeit: Schwerpunkt: Organisation und Durchführung der Ablage und Archivierung der fertigen, abgeschlossenen Chargendokumentationen in der Verpackung. Unterstützung der QA-Administrator/-innen beim Batch Record Review durch Zusammenstellung von Dokumentationen. Ggf. Unterstützung der QA-Administratorinnen beim Ausgabereview in der Verpackung. Kontrollierte Ausgabe und Verwaltung von Formularen in der Verpackung. Unterstützung des Vorgesetzten für QA-relevante Tätigkeiten bei Bedarf. Fachliche und persönliche Anforderungen: Universitäts-

  • Senior Manager, Clinical Database Applications and Reporting (m/f/d)

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Senior Manager, Clinical Database Applications and Reporting (m/f/d) Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. The Position The Associate Director, Clinical Database Applications and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert responsible for setting the overall programming strategy including the oversight, guidance, implementation, and management of clinical database applications and reporting. The responsibilities include advancing operational excellence by standardizing reporting, scaling programming strategies, automating workflows, and delivering high-quality outputs that meet user requirements by collaborating with a variety of internal and external stakeholders including leading all aspects of end-to-end programming efforts. In addition, managing quality of data validation programming deliverables, maintaining compliance and inspection readiness of clinical applications, reports, and supporting process documentation, and reporting processes are some of the key requ

  • Bioprocess Specialst (m/w/d) DSP

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Bioprocess Specialst (m/w/d) DSP Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Ab sofort suchen wir für unseren Standort in Pfaffenhofen eine/n engagierte/n Bioprocess Specialst (m/w/d) DSP Angaben zur Tätigkeit: Zum aktuellen Zeitpunkt befindet sich das Projekt und die damit verbundenen Tätigkeiten in der Etablierungsphase: Etablierungsphase Sie sind verantwortlich für die Etablierung ausgewählter DSP-Prozessschritte mit Single Use Materialien, angefangen bei der unterstützenden Geräteinbetriebnahme und -qualifizierung (DQ/IQ/OQ) Planung und Umsetzung von Leistungsqualifizierungsaktivitäten (PQ, PPQ) Erstellung und Überprüfung von Risikoanalysen, Qualifizierungs- und weiteren GMP-Dokumenten Etablierung von GMP-gerechten Herstellanweisungen (Master Batch Records) Erstellen und Überarbeiten sowie Überprüfen von Rezepten/Methoden Ihr Zuständigkeitsbereich umfasst des Weiteren Tätigkeiten im Bereich Operational Readiness (u.a. Materialmanagement; Probenhandling; Environmental, Health and Sa

  • Senior Manager (m/w/d) Audit & Supplier Qualification

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Senior Manager (m/w/d) Audit & Supplier Qualification Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position: Senior Manager (m/f/d) Audit & Supplier Qualification Roles and Responsibilities Audit Planning & Execution: Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers Prepare audit findings & reports and discuss potential impact on business Responsible for Follow-Up communication related to audits with CMOs & Suppliers and monitor CAPA implementation related to audit findings Internal consultation for risk identification with day-to-day business & QA functions related to CMOs/Suppliers Quality Agreements: Support global and regional Quality Agreement template definition Negotiate Quality Agreements with CMOs and Suppliers Involve internal stakeholders in Quality Agreement negotiations whenever required Support Integrated Risk Management

  • Mitarbeiter (Pharmakant/PTA/CTA/MTA) (m/w/d) für die Arzneimittelherstellung befristet auf 2 Jahre

    Job Location (Country/Region)

    unspecified Salary not disclosed

    Mitarbeiter (Pharmakant/PTA/CTA/MTA) (m/w/d) für die Arzneimittelherstellung befristet auf 2 Jahre Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Angaben zur Tätigkeit: Als Mitarbeiter (m/w/d) (Pharmakant/PTA/CTA/MTA) für die Arzneimittelherstellung sorgen Sie eigenständig für die Bedienung, Rüstung und Reinigung unserer Maschinen zur Herstellung von Tabletten, Filmtabletten, etc. nach Vorgabe von Herstellvorschriften Wir vertrauen Ihnen die Durchführung von Wartungs-, Kalibrierungs- und Reinigungstätigkeiten im Herstellbereich an, die Sie nach Vorgabe von Standardarbeitsanweisungen an Produktions- und Betriebsanlagen durchführen Laufende Kontrollen der Prozess- und Qualitätsparameter sowie die Durchführung und Dokumentation von In-Prozess-Kontrollen gehören ebenso zu Ihrem Aufgabenpacket Ihr Tätigkeit umfasst auch die Beachtung von Hygiene-, Sicherheits-, Betriebs- und Umweltvorschriften sowie das Arbeiten und Dokumentieren nach Vorgabe von GMP „Gute Herstellungspraxis für Arzneimittel und Wirkstoffe“ Wir freuen uns ebenso über Ihre Mitwirkung bei der verfahrenstech

  • Medical Science Liaison, GYN Oncology - West

    Work Model Remote (Daiichi Sankyo US) | Job Location (Country/Region)

    remote $151K-$226K

    Medical Science Liaison, GYN Oncology - West Work Model Remote (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Medical Science Liaison develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: AK, WA, OR, CA, AZ, NV, UT, ID, MT, Northern and West WY. Responsibilities Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo

  • Head of Bioconjugation BioDS (m/w/d)

    Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region)

    unspecified Salary not disclosed

    Head of Bioconjugation BioDS (m/w/d) Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Ab sofort suchen wir für unsere Produktionsstätte in Pfaffenhofen/Ilm eine/n engagierte/n Head of Bioconjugation BioDS (m/w/d) Angaben zur Tätigkeit: Aufbau und Leitung einer neuen Abteilung zur Herstellung von hochpotenten Antikörper-Wirkstoff-Konjugaten im mittleren Maßstab - von der Installation der Reinräume über den technischen Start-up bis zur GMP-Routineproduktion Mitgestaltung des Produktionsbereiches, der Qualifizierungs- und Validierungsstrategien, SOP-Erstellung und der GMP-Organisation im Rahmen des laufenden Neubaus Verantwortung für die Herstellung von nicht-klinischen und klinischen Prüfpräparaten sowie perspektivisch von kommerziellen Chargen Führung und Entwicklung eines interdisziplinären Teams mit bis zu 20 Mitarbeitenden Sicherstellung der Einhaltung aller relevanten GMP- und EHS-Vorgaben Budgetverantwortung für die Abteilung Enge Zusammenarbeit mit der Entwicklungsabteilung, insbesondere b