AS&T Manager – ESO Biosimilars

vor 6 Monaten

Kundl, Österreich Novartis Vollzeit
Analytical Science & Technology Manager (AS&T)– External Supply Operations ESO Biosimilars (d/f/m), Kundl, Austria or Slovenia Site

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

Your key responsibilities:

Responsibility for execution and maintenance of quality system for External Supplier Operations (ESO) Analytical Science & Technology (AS&T), including tools and processes. Support function for the QAM (Quality Assurance Manager) for solving analytical and stability questions for assigned suppliers in the scope of the ESO Biosimilars Quality organization in accordance with regulation, internal guidelines, GMP and business goals.

Your responsibilities include, but are not limited to:

- Support External Suppliers Qualification process, Tech Transfer assessments for analytical method transfers and analytical trouble shooting as needed
- Lead, implement and reports to global AS&T the requirements/programs in the assigned ESO QA Network and act as project lead in cross functional ESO AS&T project teams
- Supports defining and implements business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply
- Support Implementation of Guidelines at the assigned external partners and suppliers as well as the accountable QAM to define and maintain the ESO Stability Program at CMOs
- Lead programs and initiatives to implement changes and to remediate where required
- Support to interpret stability data, analyses trends, and provides scientifically sound conclusions for product shelf life assessments, storage conditions, packaging and transport categories
- Asses analytical Change Control records for acceptability and define studies needed to support the changes.
- Support QAM to guarantee suspect analytical results investigations are managed in agreement with Sandoz standards and the right CAPA is implemented and ensures Testing Monographs are state-of-the-art
- Further support site readiness for Health Authority inspections & participate in audits on request and escalate any issues or instances of instability per the Sandoz escalation policy

  • AS&T Manager – ESO Biosimilars

    vor 1 Monat

    Kundl, Tirol, Österreich Novartis Vollzeit

    Transformative Period for SandozSandoz is undergoing an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and...

  • As&t Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Analytical Science & Technology Manager (AS&T) - External Supply Operations ESO Biosimilars (d/f/m), Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus,...

  • AS&T Manager – ESO Biosimilars

    vor 3 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Transformative Quality Leadership OpportunitySandoz, a global leader in sustainable Generic and Biosimilar medicines, is seeking a highly skilled AS&T Manager to join our External Supply Operations team. As a key member of our Quality organization, you will be responsible for executing and maintaining our quality system, ensuring compliance with regulations,...

  • Eso Sm As&t Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Analytical Science & Technology Manager (AS&T) - External Supply Operations SM (d/f/m), Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with...

  • Technical Manager Ms&t Eso-bio Drug Product

    vor 5 Monaten

    Kundl, Österreich Sandoz Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Senior Technical Manager Ms&t Eso-bio Drug Product

    vor 5 Monaten

    Kundl, Österreich Sandoz Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Eso Sm Quality Assurance Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **ESO Quality Assurance Manager (d/f/m), Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business...

  • Regulatory Affairs Manager; Biosimilars

    vor 2 Monaten

    Kundl, Österreich Sandoz Vollzeit

    **Regulatory Affairs Manager; Biosimilars (d/f/m)** **Biosimilars, Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set...

  • Lab Technician Ms&t

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Lab Technician MS&T (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere Geschäftsziele...

  • QA Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Manager (d/f/m) ESO, Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives,...

  • Ra Cmc Senior Manager Biosimilars

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Regulatory CMC Senior Manager Biosimilars (M/F/d), Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer...

  • Senior Process Expert

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior Process Expert (d/w/m), Kundl, Tirol, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere...

  • Senior Technical Manager Ms&t

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior Technical Manager MS&T (d/f/m), Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business...

  • Manager Regulatory Affairs

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Manager Regulatory Affairs (d/f/m), Kundl, Tyrol, Austria** 8! This is the number of high-quality biosimilars for which Sandoz has already received a marketing authorization, and that provided increased access to life-saving medicines to patients worldwide. Additionally, Sandoz has a rich pipeline of further biosimilars under development. As a Manager...

  • Technical Manager Ms&t Eso-bio

    vor 5 Monaten

    Kundl, Österreich Sandoz Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Senior QA Gmp Facilitator Ii

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior QA GMP Facilitator II (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere...

  • Process Expert

    vor 1 Monat

    Kundl, Österreich Sandoz Vollzeit

    Ihre Aufgaben sind unter anderem: - Management und Untersuchung aller intern und extern eingegangenen produktbezogenen Abweichungen/Reklamationen, deren Dokumentation und Durchführung notwendiger Korrektur - und Vorbeugemaßnahmen, Rückführung von Reklamationen auf den Herstellprozess. - Unterstützung des Bereichs MS&T bei der Durchführung von...

  • QA Gmp Facilitator I

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA GMP Facilitator I (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere Geschäftsziele...

  • QA Gmp Facilitator Ii

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA GMP Facilitator II (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere Geschäftsziele...

  • Quality Head Large Molecules and Injectables

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Quality Head Large Molecules and Injectables (d/f/m), Global Quality STO, Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater...