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Manager of Analytical Science

vor 3 Monaten

Kundl, Tirol, Österreich Novartis Vollzeit
Manager of Analytical Science & Technology (AS&T) – External Supply Operations for Biosimilars


Novartis is navigating an exhilarating and transformative phase as a prominent leader and innovative provider of sustainable Generic and Biosimilar medicines.


As an independently operating entity, Novartis aims to sharpen its strategic focus, enhance agility, establish clearer business objectives, improve shareholder returns, and cultivate a robust culture for our associates.

This is a pivotal moment in our journey, and by forging a new and ambitious direction, it will offer a unique opportunity for all of us, both professionally and personally.

Join us as a pioneer in our evolving Novartis

Your primary responsibilities include:


Overseeing the execution and upkeep of the quality system for External Supplier Operations (ESO) within Analytical Science & Technology (AS&T), encompassing essential tools and processes.

Providing support to the Quality Assurance Manager (QAM) in addressing analytical and stability inquiries for designated suppliers within the ESO Biosimilars Quality framework, adhering to regulations, internal guidelines, GMP, and business objectives.


Your responsibilities encompass, but are not limited to:

  • Facilitating the External Suppliers Qualification process, conducting Tech Transfer evaluations for analytical method transitions, and troubleshooting analytical issues as necessary.
  • Leading, implementing, and reporting to global AS&T on the requirements/programs within the assigned ESO QA Network, acting as the project lead in cross-functional ESO AS&T project teams.
  • Assisting in defining and implementing business processes and SOPs/GOPS essential for maintaining a robust AS&T Quality System within External Supply.
  • Supporting the implementation of Guidelines at designated external partners and suppliers, alongside the accountable QAM, to establish and uphold the ESO Stability Program at Contract Manufacturing Organizations (CMOs).
  • Driving programs and initiatives to implement changes and remediate issues where necessary.
  • Assisting in the interpretation of stability data, analyzing trends, and providing scientifically sound conclusions for product shelf life evaluations, storage conditions, packaging, and transport categories.
  • Evaluating analytical Change Control records for acceptability and determining studies required to support the changes.
  • Supporting the QAM in ensuring that investigations of suspect analytical results are conducted in accordance with Novartis standards, with appropriate CAPA implementation, and ensuring Testing Monographs are up-to-date.
  • Further supporting site readiness for Health Authority inspections and participating in audits as requested, while escalating any issues or instances of instability per the Novartis escalation policy.