Takeda (vormals Shire / Baxalta / Baxter) Jobs in Wien

Great understand of data and sources * Strategist in cooperation with IT development team, developing a process to collect, ingest and deliver data along with proper data models for analytical needs * Develop solutions with recommended data model and business intelligence technologies including data warehouse, data marts, OLAP modeling, dashboards/reporting, and data queries * Collaborate with Enterprise Data and Analytics Team to design data visualization solutions that synthesize complex data for data mining and discovery * Bachelors' Degree, from an accredited institution in Data Science, Statistics, Computer Science, or related field * 2 - 3 years of experience in BI application development, and experience with data warehousing and reporting tools - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit Great understand of data and sources * Strategist in cooperation with IT development team, developing a process to collect, ingest and deliver data along with proper data models for analytical needs * Develop solutions with recommended data model and business intelligence technologies including data warehouse, data marts, OLAP modeling, dashboards/reporting, and data queries * Collaborate with Enterprise Data and Analytics Team to design data visualization solutions that synthesize complex data for data mining and discovery * Bachelors' Degree, from an accredited institution in Data Science, Statistics, Computer Science, or related field * 2 - 3 years of experience in BI application development, and experience with data warehousing and reporting tools - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit
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As a QRM Leader, you will be a vital contributor to our inspiring, bold mission. The Quality Risk Management (QRM) Leader is responsible for providing systematic and operational expertise to the management of a comprehensive and integrated risk management program which meets applicable internal and external standards for drug, device and biologics manufacturing. Join us as a Quality Risk Management Lead in our Cambridge, MA or Vienna, Austria office. The QRM Lead will be key to the success of the Quality Risk Management program and will provide direct support and mentoring to our Sites and OpUs to ensure appropriate execution of the Risk Management program. * Proven ability to lead by directing change as well as by influence on areas not within direct control. * Lead and drive collaborations with cross-functional teams to accomplish objectives. As a QRM Leader, you will be a vital contributor to our inspiring, bold mission. The Quality Risk Management (QRM) Leader is responsible for providing systematic and operational expertise to the management of a comprehensive and integrated risk management program which meets applicable internal and external standards for drug, device and biologics manufacturing. Join us as a Quality Risk Management Lead in our Cambridge, MA or Vienna, Austria office. The QRM Lead will be key to the success of the Quality Risk Management program and will provide direct support and mentoring to our Sites and OpUs to ensure appropriate execution of the Risk Management program. * Proven ability to lead by directing change as well as by influence on areas not within direct control. * Lead and drive collaborations with cross-functional teams to accomplish objectives.
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Abgeschlossene höhere chemisch- technische Ausbildung (Chemotechniker, HTL-Chemie o.Ä.) Als ChemotechnikerIn tragen Sie Verantwortung für Kriterien wie ph-Wert, Temperatur, Leitfähigkeit oder Proteinkonzentration und spielen so eine wichtige Rolle in der Betreuung der Produkte während des Produktionsprozesses nach GMP. Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - In der Alkoholfraktionierung werden durch verschiedene Fällungs- und Separationsmethoden Zwischenprodukte aus humanem Blutplasma hergestellt. * Selbstständige Durchführung der Verfahrensschritte gemäß gültigen GMP u. GDP-Vorschriften (Good Manufacturing Practice, Good Documentation Practice) * Arbeiten anhand standardisierter Arbeitsanweisungen und Erarbeitung solcher * Berechnung und Einwaage von Pufferlösungen und Blutplasma-Alkohol-Mischungen Abgeschlossene höhere chemisch- technische Ausbildung (Chemotechniker, HTL-Chemie o.Ä.) Als ChemotechnikerIn tragen Sie Verantwortung für Kriterien wie ph-Wert, Temperatur, Leitfähigkeit oder Proteinkonzentration und spielen so eine wichtige Rolle in der Betreuung der Produkte während des Produktionsprozesses nach GMP. Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - In der Alkoholfraktionierung werden durch verschiedene Fällungs- und Separationsmethoden Zwischenprodukte aus humanem Blutplasma hergestellt. * Selbstständige Durchführung der Verfahrensschritte gemäß gültigen GMP u. GDP-Vorschriften (Good Manufacturing Practice, Good Documentation Practice) * Arbeiten anhand standardisierter Arbeitsanweisungen und Erarbeitung solcher * Berechnung und Einwaage von Pufferlösungen und Blutplasma-Alkohol-Mischungen
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Als Process Engineering Lead sind Sie verantwortlich für das Design und die Implementierung von Produktionsanlagen, die in verschiedenen Fertigungsbereichen eingesetzt werden. Unsere hochspezialisierten TechnikerInnen im Site Engineering kümmern sich in den verschiedenen Fachbereichen, wie Utility Engineering, Process Engineering, Planning & Scheduling, Reliability Engineering und Maintenance um den gesamten Lebenszyklus der Assets – von Neuanlagen bis hin zu kontinuierlicher Verbesserung und dem Ausscheiden von Produktionsanlagen. * Mitarbeiterführung, Budget- und Projektverantwortung sowie Aufgaben zur Sicherstellung einer effektiven Organisation im Bereich Process Engineering - Takeda (vormals Shire / Baxalta / Baxter) * Vienna * Feste Anstellung * Vollzeit - Site Engineering verantwortet an den Wiener Produktionsstandorten alle Anlagen, Gebäude, Infrastruktur und den Support. Als Process Engineering Lead sind Sie verantwortlich für das Design und die Implementierung von Produktionsanlagen, die in verschiedenen Fertigungsbereichen eingesetzt werden. Unsere hochspezialisierten TechnikerInnen im Site Engineering kümmern sich in den verschiedenen Fachbereichen, wie Utility Engineering, Process Engineering, Planning & Scheduling, Reliability Engineering und Maintenance um den gesamten Lebenszyklus der Assets – von Neuanlagen bis hin zu kontinuierlicher Verbesserung und dem Ausscheiden von Produktionsanlagen. * Mitarbeiterführung, Budget- und Projektverantwortung sowie Aufgaben zur Sicherstellung einer effektiven Organisation im Bereich Process Engineering - Takeda (vormals Shire / Baxalta / Baxter) * Vienna * Feste Anstellung * Vollzeit - Site Engineering verantwortet an den Wiener Produktionsstandorten alle Anlagen, Gebäude, Infrastruktur und den Support.
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Defines value chain improvements and associated business cases - The Business Excellence Lead for the Plasma Operating Unit (Plasma OpU) of the Plasma Operating Unit Business Excellence and the Plasma OpU Leadership team to develop and implement strategies and tactical plans to enable the team to improve performance across the Operating Unit. * Maintains cross-functional relationships across the Global GMSGQ network to ensure business operations are performed in alignment with GMSGQ/Takeda vision and goals. * Creates alignment across the Plasma OpU around a proven set of best practices through the creation and maintenance of a Project Portfolio Governance Process while aligning with functional business partners and with the other OpUs and GMS regions as required. * Solid understanding of the role of the OpU and how it contributes to achieving the broader business objectives. Defines value chain improvements and associated business cases - The Business Excellence Lead for the Plasma Operating Unit (Plasma OpU) of the Plasma Operating Unit Business Excellence and the Plasma OpU Leadership team to develop and implement strategies and tactical plans to enable the team to improve performance across the Operating Unit. * Maintains cross-functional relationships across the Global GMSGQ network to ensure business operations are performed in alignment with GMSGQ/Takeda vision and goals. * Creates alignment across the Plasma OpU around a proven set of best practices through the creation and maintenance of a Project Portfolio Governance Process while aligning with functional business partners and with the other OpUs and GMS regions as required. * Solid understanding of the role of the OpU and how it contributes to achieving the broader business objectives.
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Als Mitarbeiter im Team der Quality Control Sample Logistics Wien sind Sie überwiegend mit Probenvorbereitung und Testprobenlogistik betraut. Takeda (vormals Shire / Baxalta / Baxter) * Vienna * Befristeter Vertrag * Vollzeit - Achtung: Diese Stelle ist befristet, könnte jedoch für Sie ein guter Einstieg in die Pharmaindustrie bedeuten! * Probenherstellung und Aliquotierung * Probenverteilung und Probenannahme von Zwischen- und Endprodukten * Probenverteilung und Verwaltung von Stabilitätsstudien * Probenweiterleitung an interne und externe QC Labore * Probenkontrolle sowie Ein-/um-/auslagern aus den Lagerräumen der Sample Logistics * Probenbeschaffung aus dem Zentrallager * Aktive Teilnahme an Besprechungen sowie an der Planung und Durchführung von Projekten * Erstellen und Bearbeitung von Abweichungen * Überarbeiten und Erstellen von Dokumenten (SOP, WI, Formularen;...) * Messmittelverantwortung Als Mitarbeiter im Team der Quality Control Sample Logistics Wien sind Sie überwiegend mit Probenvorbereitung und Testprobenlogistik betraut. Takeda (vormals Shire / Baxalta / Baxter) * Vienna * Befristeter Vertrag * Vollzeit - Achtung: Diese Stelle ist befristet, könnte jedoch für Sie ein guter Einstieg in die Pharmaindustrie bedeuten! * Probenherstellung und Aliquotierung * Probenverteilung und Probenannahme von Zwischen- und Endprodukten * Probenverteilung und Verwaltung von Stabilitätsstudien * Probenweiterleitung an interne und externe QC Labore * Probenkontrolle sowie Ein-/um-/auslagern aus den Lagerräumen der Sample Logistics * Probenbeschaffung aus dem Zentrallager * Aktive Teilnahme an Besprechungen sowie an der Planung und Durchführung von Projekten * Erstellen und Bearbeitung von Abweichungen * Überarbeiten und Erstellen von Dokumenten (SOP, WI, Formularen;...) * Messmittelverantwortung
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Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - Die Instandhaltung bei Takeda bietet den Produktionsabteilungen Unterstützung in allen technischen Belangen und ist verantwortlich für die vorbeugende Wartung und Reparatur bzw. Instandsetzung von pharmazeutischen Produktionsanlagen und Supportsystemen wie z.B. Wasserversorgung und Konzentratversorgung. * Periodische Wartungsarbeiten und Reparaturen zur Erhaltung eines einwandfreien Zustands der technischen Betriebssysteme und Produktionsanlagen * Technische Betreuung von hochautomatisierten Anlagen * Kalibrierung von Produktion und Versorgungsanlagen * Betreiben von Supportsystemen * Teilnahme an der etablierten Rufbereitschaft (wird zusätzlich bezahlt) * Arbeiten in der Tagesschicht, 38-Stunden Woche Mon-Son * Technische abgeschlossene Lehre (Mechatronik, Elektrotechnik...) Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - Die Instandhaltung bei Takeda bietet den Produktionsabteilungen Unterstützung in allen technischen Belangen und ist verantwortlich für die vorbeugende Wartung und Reparatur bzw. Instandsetzung von pharmazeutischen Produktionsanlagen und Supportsystemen wie z.B. Wasserversorgung und Konzentratversorgung. * Periodische Wartungsarbeiten und Reparaturen zur Erhaltung eines einwandfreien Zustands der technischen Betriebssysteme und Produktionsanlagen * Technische Betreuung von hochautomatisierten Anlagen * Kalibrierung von Produktion und Versorgungsanlagen * Betreiben von Supportsystemen * Teilnahme an der etablierten Rufbereitschaft (wird zusätzlich bezahlt) * Arbeiten in der Tagesschicht, 38-Stunden Woche Mon-Son * Technische abgeschlossene Lehre (Mechatronik, Elektrotechnik...)
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We are looking for a strong candidate for the position as a national Medical Scientific Liaison Manager (Oncology), who will be responsible for whole of Austria (approximately 70% travel activity). * Strategically engages stakeholders in key medical activities in alignment with the Medical Manager for local activities as well as with the headquarter for international activities (e.g. Advisory boards, training, publication, data generation and peer-to-peer educational activities) * Captures and shares in-field insights to support medical and scientific strategy and business development. * Answers medical/technical unsolicited inquiries from HCPs, provide accurate and non-promotional scientific information relating to licensed and unlicensed indications following We are looking for a strong candidate for the position as a national Medical Scientific Liaison Manager (Oncology), who will be responsible for whole of Austria (approximately 70% travel activity). * Strategically engages stakeholders in key medical activities in alignment with the Medical Manager for local activities as well as with the headquarter for international activities (e.g. Advisory boards, training, publication, data generation and peer-to-peer educational activities) * Captures and shares in-field insights to support medical and scientific strategy and business development. * Answers medical/technical unsolicited inquiries from HCPs, provide accurate and non-promotional scientific information relating to licensed and unlicensed indications following
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The Sr Research Scientist is responsible for driving new, innovative programs to improve the process, and product quality of plasma-derived therapies, optimized for patients. * The incoming scientist must be comfortable with working in a fast-paced environment and feel comfortable with ambiguity and changing priorities - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - Plasme-Derived Therapies R&D focuses first and foremost on developing therapies that will improve the health care outcomes of patients Takeda aims to serve. This includes evaluation and process development of new complex new products, alternative fractionation technologies and extraction of new plasma proteins. * Explore innovative methods / projects / programs to improve the quality and efficient production of plasma-derived therapies for global and local distribution The Sr Research Scientist is responsible for driving new, innovative programs to improve the process, and product quality of plasma-derived therapies, optimized for patients. * The incoming scientist must be comfortable with working in a fast-paced environment and feel comfortable with ambiguity and changing priorities - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - Plasme-Derived Therapies R&D focuses first and foremost on developing therapies that will improve the health care outcomes of patients Takeda aims to serve. This includes evaluation and process development of new complex new products, alternative fractionation technologies and extraction of new plasma proteins. * Explore innovative methods / projects / programs to improve the quality and efficient production of plasma-derived therapies for global and local distribution
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Serves as a champion of Shire's Project Management Methodology and associated Project Management Office processes, recognizing how project results seriously impact the overall success of the organization - Align, synergizes with the Product Operations Leads (POLs) and other key stakeholders. * Drives accountability and track progress for milestone hit rate of Product Operations program/projects * Product Operations Program Manager is providing PM leadership to a diverse, geographically distributed group of functional team members and subject matter experts with different cultural backgrounds. * Set up, scopes, execution of global strategic x-functional product specific projects/task forces and GMS Product Team sub-teams * mapping and ensures implementation of GMS product governance throughout all projects Serves as a champion of Shire's Project Management Methodology and associated Project Management Office processes, recognizing how project results seriously impact the overall success of the organization - Align, synergizes with the Product Operations Leads (POLs) and other key stakeholders. * Drives accountability and track progress for milestone hit rate of Product Operations program/projects * Product Operations Program Manager is providing PM leadership to a diverse, geographically distributed group of functional team members and subject matter experts with different cultural backgrounds. * Set up, scopes, execution of global strategic x-functional product specific projects/task forces and GMS Product Team sub-teams * mapping and ensures implementation of GMS product governance throughout all projects
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Develop and lead efforts to establish integrated and sustainable Regulatory Intelligence strategies, processes, and activities for our products (clincial and commercial) enabling a sustainable existence on the market * Global leadership and primary accountability for design and sustainability of overall Regulatory Intelligence strategies and processes for Takeda * Responsible for the establishment and day to day operations of Regulatory Intelligence for Takeda and communication of any trends or concerns to our senior leadership Develop and lead efforts to establish integrated and sustainable Regulatory Intelligence strategies, processes, and activities for our products (clincial and commercial) enabling a sustainable existence on the market * Global leadership and primary accountability for design and sustainability of overall Regulatory Intelligence strategies and processes for Takeda * Responsible for the establishment and day to day operations of Regulatory Intelligence for Takeda and communication of any trends or concerns to our senior leadership
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Planning, execution, documentation and reporting of biological device related studies (biological compatibility, in use, feasibility and comparability studies) to support clinical studies (I to III), life cycle management activities as well as internal medical device development activities * Implement method qualifications for several products to support device qualification studies with main focus on subvisible particle measurements using Light obscuration (LO) and Micro Flow Imaging (MFI); including also method development * More than 3 years of experience gained within the biopharmaceutical industry or academia in validation and development work on analytical methods and project management. Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit * Support of special investigations with the main focus on subvisible particle measurements Planning, execution, documentation and reporting of biological device related studies (biological compatibility, in use, feasibility and comparability studies) to support clinical studies (I to III), life cycle management activities as well as internal medical device development activities * Implement method qualifications for several products to support device qualification studies with main focus on subvisible particle measurements using Light obscuration (LO) and Micro Flow Imaging (MFI); including also method development * More than 3 years of experience gained within the biopharmaceutical industry or academia in validation and development work on analytical methods and project management. Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit * Support of special investigations with the main focus on subvisible particle measurements
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Provide strategic leadership of Medical personnel (e.g. Please select, adapt or add functions in the medical department, - Medical Advisors, Medical Scientific Liaison (Manager), Regulatory Affairs, Pharmacovigilance, Quality Assurance and Clinical Operations personnel) * Manage and develop Medical personnel in order to achieve optimal performance * Represent local medical functions in a professional and competent manner towards internal and external stakeholders; ensure alignment across all departments - o Lead local processes to hire new medical personnel - o Support on-boarding, training and knowledge transfer together with Regional Medical Affairs (RMA) within the medical department providing an upskilling on negotiations and networking - o Planning and control of medical department plans and budget * Medical/Scientific Affairs Provide strategic leadership of Medical personnel (e.g. Please select, adapt or add functions in the medical department, - Medical Advisors, Medical Scientific Liaison (Manager), Regulatory Affairs, Pharmacovigilance, Quality Assurance and Clinical Operations personnel) * Manage and develop Medical personnel in order to achieve optimal performance * Represent local medical functions in a professional and competent manner towards internal and external stakeholders; ensure alignment across all departments - o Lead local processes to hire new medical personnel - o Support on-boarding, training and knowledge transfer together with Regional Medical Affairs (RMA) within the medical department providing an upskilling on negotiations and networking - o Planning and control of medical department plans and budget * Medical/Scientific Affairs
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Abgeschlossene technische Lehre aus den Berufsfeldern: Wissenschaft, Forschung und Entwicklung (bspw. MedizintechnikerIn), Elektrotechnik, Elektronik und Telekommunikation (bspw. MechatronikerIn), Maschinen, KFZ und Metall (bspw. MetalltechnikerIn) * Mehrjährige Berufserfahrung in Maschinenbaubetrieben bzw. Produktionsbetrieben - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - Anlagenbetreuung und Mitarbeit in der Produktion inkl. notwendiger Dokumentationsschritte, wie z.B. * Beschickung und Überwachung der Abfüllanlagen * Verpackung der verfüllten Produkte * Durchführung von Kontrollen und In-Prozess-Kontrollen * Durchführung von Anlagenreinigung/ -desinfektionen * Dokumentation im Batch Record (BR) / in Formularen entsprechend GDP-Vorgaben * Einhaltung der gültigen SOPs und Hygienevorschriften Abgeschlossene technische Lehre aus den Berufsfeldern: Wissenschaft, Forschung und Entwicklung (bspw. MedizintechnikerIn), Elektrotechnik, Elektronik und Telekommunikation (bspw. MechatronikerIn), Maschinen, KFZ und Metall (bspw. MetalltechnikerIn) * Mehrjährige Berufserfahrung in Maschinenbaubetrieben bzw. Produktionsbetrieben - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - Anlagenbetreuung und Mitarbeit in der Produktion inkl. notwendiger Dokumentationsschritte, wie z.B. * Beschickung und Überwachung der Abfüllanlagen * Verpackung der verfüllten Produkte * Durchführung von Kontrollen und In-Prozess-Kontrollen * Durchführung von Anlagenreinigung/ -desinfektionen * Dokumentation im Batch Record (BR) / in Formularen entsprechend GDP-Vorgaben * Einhaltung der gültigen SOPs und Hygienevorschriften
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Responsible for setting the vision, defining the Business Unit (BU) strategy, ensuring execution of brand and key account plans to achieve ambitious goals * Leads the BU team members and cross-functional team to deliver a superior patient & customer experience, exceed expectations of key customers, ensuring access and become best-in-class in the areas where we are present * Solid understanding of the business model, treatment pathways and the market environment of the BU * Fully accountable for the local business, including currently marketed products and any future products in this therapy area * Develops a strategy in close cooperation with cross-functional team members (medical, marketing, sales, market access, business support etc.) * Ensures implementation of policies and programs to achieve maximum sales and profit Responsible for setting the vision, defining the Business Unit (BU) strategy, ensuring execution of brand and key account plans to achieve ambitious goals * Leads the BU team members and cross-functional team to deliver a superior patient & customer experience, exceed expectations of key customers, ensuring access and become best-in-class in the areas where we are present * Solid understanding of the business model, treatment pathways and the market environment of the BU * Fully accountable for the local business, including currently marketed products and any future products in this therapy area * Develops a strategy in close cooperation with cross-functional team members (medical, marketing, sales, market access, business support etc.) * Ensures implementation of policies and programs to achieve maximum sales and profit
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Global leadership and primary accountability for design and sustainability of overall Data Integrity strategies and processes * Responsible for the establishment and day to day operations of Data Integrity and communication of any trends or concerns to the leadership team * Develop and lead efforts to establish integrated and sustainable Data Integrity strategies, processes, and activities for our clinical and commercial products enabling a sustainable existence on the market * Define and implement a collaborative process with GMSGQ functions and other business functions and stakeholders to execute Data Integrity strategies including but not limited to integrated processes for all OpUs and Regions, R&D processes, Governance Forums, and support Data Integrity due diligence evaluations for the integration of Takeda acquisitions Global leadership and primary accountability for design and sustainability of overall Data Integrity strategies and processes * Responsible for the establishment and day to day operations of Data Integrity and communication of any trends or concerns to the leadership team * Develop and lead efforts to establish integrated and sustainable Data Integrity strategies, processes, and activities for our clinical and commercial products enabling a sustainable existence on the market * Define and implement a collaborative process with GMSGQ functions and other business functions and stakeholders to execute Data Integrity strategies including but not limited to integrated processes for all OpUs and Regions, R&D processes, Governance Forums, and support Data Integrity due diligence evaluations for the integration of Takeda acquisitions
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The Research Scientist is responsible for driving new, innovative programs to improve the process, and product quality of plasma-derived therapies, optimized for patients. * The incoming scientist must be comfortable with working in a fast-paced environment and comfortable with ambiguity and changing priorities - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - The Plasma-Derived Therapies R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. This includes evaluation and process development of new products, alternative fractionation technologies and extraction of new plasma proteins. * Explores innovative methods / projects / programs to improve the quality and efficient production of plasma-derived therapies for global and local distribution The Research Scientist is responsible for driving new, innovative programs to improve the process, and product quality of plasma-derived therapies, optimized for patients. * The incoming scientist must be comfortable with working in a fast-paced environment and comfortable with ambiguity and changing priorities - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit - The Plasma-Derived Therapies R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. This includes evaluation and process development of new products, alternative fractionation technologies and extraction of new plasma proteins. * Explores innovative methods / projects / programs to improve the quality and efficient production of plasma-derived therapies for global and local distribution
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The core purpose of the position is to support quality activities related to oversight of Contract Manufacturing Operations (CMO) performed on behalf of Takeda. * Supporting any GMP, Quality and Compliance activities as required * Prepares reports and maintains quality metrics (in particular related to disposition processes) and makes recommendations to management * Authoring, revising and/or reviewing Takeda's Standard Operating Procedures, Guidance Documents, Technical/Quality Agreements, and other documents as assigned * Assisting in the preparation of Annual Product (Quality) Reviews (APR/APQR), complaint investigations, change controls as assigned deviations * Acting Quality Representative for projects * Minimum of 5 years of experience in a Quality Assurace or compliance related position within the pharmaceutical industry The core purpose of the position is to support quality activities related to oversight of Contract Manufacturing Operations (CMO) performed on behalf of Takeda. * Supporting any GMP, Quality and Compliance activities as required * Prepares reports and maintains quality metrics (in particular related to disposition processes) and makes recommendations to management * Authoring, revising and/or reviewing Takeda's Standard Operating Procedures, Guidance Documents, Technical/Quality Agreements, and other documents as assigned * Assisting in the preparation of Annual Product (Quality) Reviews (APR/APQR), complaint investigations, change controls as assigned deviations * Acting Quality Representative for projects * Minimum of 5 years of experience in a Quality Assurace or compliance related position within the pharmaceutical industry
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Responsibility for development and technology transfer for the process steps formulation, sterile filtration, filling and lyophilization (FFF) * Support of Process transfer, Quality by design, submissions, briefing packages and technical troubleshooting for the Takeda DP portfolio * Authoring study plans, reports and development submission sections - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Befristeter Vertrag * Vollzeit * Build and maintain comprehensive expert knowledge of all FFF-related process steps * Participation in best practice and knowledge sharing across different teams * Support/ lead of critical manufacturing investigations and regulatory inspections if required * Coordinate and if required participate in the execution of studies * MSc degree or equivalent in a Scientific field is required * Experience in Pharmaceutical and/or Bioprocessing industry * Statistical skills Responsibility for development and technology transfer for the process steps formulation, sterile filtration, filling and lyophilization (FFF) * Support of Process transfer, Quality by design, submissions, briefing packages and technical troubleshooting for the Takeda DP portfolio * Authoring study plans, reports and development submission sections - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Befristeter Vertrag * Vollzeit * Build and maintain comprehensive expert knowledge of all FFF-related process steps * Participation in best practice and knowledge sharing across different teams * Support/ lead of critical manufacturing investigations and regulatory inspections if required * Coordinate and if required participate in the execution of studies * MSc degree or equivalent in a Scientific field is required * Experience in Pharmaceutical and/or Bioprocessing industry * Statistical skills
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Company medical officer Takeda (vormals Shire / Baxalta / Baxter) * Vienna * Feste Anstellung * Vollzeit * Leads, owns and drives strategic global (multi-site, multi-product) microbiology/aseptic programs, initiatives and improvement activities * Leads and/or supports Contamination Investigations (Rapid Response) on-site or remote * Leads and drives network-wide Contamination Control Program * Identifies, drives and aligns implementation of new technologies (Rapid Microbiological Methods - RMM) * Leads network-wide microbiology/aseptic/RMM related Communities of Practice, drives knowledge management and represents Takeda in microbiology related forums, seminars, platforms, conferences, and publications * Supports sites regarding microbiology/aseptic related challenges and questions * Organizes and facilitates subject specific Global Communities of Practice calls/meetings Company medical officer Takeda (vormals Shire / Baxalta / Baxter) * Vienna * Feste Anstellung * Vollzeit * Leads, owns and drives strategic global (multi-site, multi-product) microbiology/aseptic programs, initiatives and improvement activities * Leads and/or supports Contamination Investigations (Rapid Response) on-site or remote * Leads and drives network-wide Contamination Control Program * Identifies, drives and aligns implementation of new technologies (Rapid Microbiological Methods - RMM) * Leads network-wide microbiology/aseptic/RMM related Communities of Practice, drives knowledge management and represents Takeda in microbiology related forums, seminars, platforms, conferences, and publications * Supports sites regarding microbiology/aseptic related challenges and questions * Organizes and facilitates subject specific Global Communities of Practice calls/meetings
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Lead the operations of the laboratory for Particle Testing EU * Lead and Develop Specialists and junior staff members * Strong people management skills in order to lead, influence and develop Supervisors and junior staff - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit * Responsible for the organization and performance of testing and for the implementation of new technologies as well as analytical method portfolio for particle testing in alignment with the different laboratories * Plan, organize and approve particle tests, related documentation, qualifications, investigations, SOPs, CAPAs and related procedures * Enhance continuous improvement programs and initiatives * Ensure compliance with GxP guidelines and regulatory requirements (e.g. Pharmacopeia) * Prepare and present documents from the laboratory during an inspection/ audit Lead the operations of the laboratory for Particle Testing EU * Lead and Develop Specialists and junior staff members * Strong people management skills in order to lead, influence and develop Supervisors and junior staff - Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit * Responsible for the organization and performance of testing and for the implementation of new technologies as well as analytical method portfolio for particle testing in alignment with the different laboratories * Plan, organize and approve particle tests, related documentation, qualifications, investigations, SOPs, CAPAs and related procedures * Enhance continuous improvement programs and initiatives * Ensure compliance with GxP guidelines and regulatory requirements (e.g. Pharmacopeia) * Prepare and present documents from the laboratory during an inspection/ audit
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Laufendes FH Studium (Pflichtpraktikum) Takeda (vormals Shire / Baxalta / Baxter) * Wien * Befristeter Vertrag * Vollzeit * Übernahme von Tätigkeiten im operativen HR-Management (z.B. Dienstzeugnisse) * Eigenständige Vorbereitung von Dokumenten für den digitalen Personalakt * Vorbereitungsarbeiten für die Payroll * Unterstützung des Eintritts- und Austritts-Prozesses * Unterstützung bei Listenerstellung- und Auswertung * Mitarbeit bei der Optimierung von HR Prozessen * Teilnahme an Meetings * Ausgezeichnete MS Office (insbesondere Excel) Kenntnisse * Gute Kommunikationsfähigkeit (deutsch/englisch) * Hands-on Mentalität * Zeitraum: ab März 2020 - für 6 Monate - Als weltweit führendes biopharmazeutisches Unternehmen mit der Mission „Better Health, Brighter Future“ stellen wir uns tagtäglich in den Dienst des Patienten. Unser Herzstück sind engagierte Kollegen – Takeda fördert uns durch Trainings, Job Rotations und Mentoring. Laufendes FH Studium (Pflichtpraktikum) Takeda (vormals Shire / Baxalta / Baxter) * Wien * Befristeter Vertrag * Vollzeit * Übernahme von Tätigkeiten im operativen HR-Management (z.B. Dienstzeugnisse) * Eigenständige Vorbereitung von Dokumenten für den digitalen Personalakt * Vorbereitungsarbeiten für die Payroll * Unterstützung des Eintritts- und Austritts-Prozesses * Unterstützung bei Listenerstellung- und Auswertung * Mitarbeit bei der Optimierung von HR Prozessen * Teilnahme an Meetings * Ausgezeichnete MS Office (insbesondere Excel) Kenntnisse * Gute Kommunikationsfähigkeit (deutsch/englisch) * Hands-on Mentalität * Zeitraum: ab März 2020 - für 6 Monate - Als weltweit führendes biopharmazeutisches Unternehmen mit der Mission „Better Health, Brighter Future“ stellen wir uns tagtäglich in den Dienst des Patienten. Unser Herzstück sind engagierte Kollegen – Takeda fördert uns durch Trainings, Job Rotations und Mentoring.
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Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit * Erstellung, Bearbeitung und Nachverfolgung von Produktionsabweichungen und Koordination von Maßnahmen zur nachhaltigen Vermeidung eines Wiederauftretens * Koordination, Moderation und strukturierte Dokumentation von Ursachenanalysen und Problemlösungen * Erstellung, Bearbeitung und Nachverfolgung von Änderungsanträgen (Change Control) * Leitung und/oder Unterstützung von Change-Projekten * Enge Zusammenarbeit mit interdisziplinären Expertenteams und Produzenten * Unterstützung und Koordination von Tätigkeiten rund um Audits * Unterstützung bei der Koordination und Kontrolle des Projektportfolios der Betriebsstätte * Aktive Mitarbeit an der kontinuierlichen Verbesserung von Abläufen in der Betriebsstätte Takeda (vormals Shire / Baxalta / Baxter) * Wien * Feste Anstellung * Vollzeit * Erstellung, Bearbeitung und Nachverfolgung von Produktionsabweichungen und Koordination von Maßnahmen zur nachhaltigen Vermeidung eines Wiederauftretens * Koordination, Moderation und strukturierte Dokumentation von Ursachenanalysen und Problemlösungen * Erstellung, Bearbeitung und Nachverfolgung von Änderungsanträgen (Change Control) * Leitung und/oder Unterstützung von Change-Projekten * Enge Zusammenarbeit mit interdisziplinären Expertenteams und Produzenten * Unterstützung und Koordination von Tätigkeiten rund um Audits * Unterstützung bei der Koordination und Kontrolle des Projektportfolios der Betriebsstätte * Aktive Mitarbeit an der kontinuierlichen Verbesserung von Abläufen in der Betriebsstätte
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