AS&T Lead for Biosimilars – External Supplier Management

vor 4 Wochen

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


Novartis is currently navigating an exciting transformation as a global frontrunner and innovative provider of sustainable Generic and Biosimilar medications.


As an independently operating entity, Novartis is committed to enhancing its strategic focus, improving agility, establishing clearer business objectives, increasing shareholder value, and fostering a robust culture for all associates.

This pivotal moment in our evolution presents a unique opportunity for professional and personal growth.

Join us in shaping the future of Novartis.


Your primary responsibilities include:


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

Providing support to the Quality Assurance Manager (QAM) in addressing analytical and stability inquiries related to designated suppliers within the ESO Biosimilars Quality framework, ensuring compliance with regulations, internal protocols, Good Manufacturing Practices (GMP), and business objectives.


Your duties 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 required.
  • Leading, implementing, and reporting to global AS&T on the requirements/programs within the assigned ESO Quality Assurance Network, acting as the project lead in cross-functional ESO AS&T project teams.
  • Assisting in the definition and implementation of business processes and Standard Operating Procedures (SOPs) necessary to uphold a robust AS&T Quality System within External Supply.
  • Supporting the application of Guidelines at designated external partners and suppliers, collaborating with the accountable QAM to establish and maintain the ESO Stability Program at Contract Manufacturing Organizations (CMOs).
  • Driving initiatives and programs to implement changes and address remediation 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, implementing appropriate Corrective and Preventive Actions (CAPA), 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 in line with Novartis escalation policies.

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