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 Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!
Your Key Responsibilities:
* Support External Suppliers Qualification process, Tech Transfer assessments for analytical method transfers and analytical trouble shooting as needed
* Lead, implement and report 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
* Support defining and implementing 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, analyze trends, and provide scientifically sound conclusions for product shelf-life assessments, storage conditions, packaging and transport categories
* Assess 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
What you’ll bring to the role:
* Higher university degree (e.g. Ph.D.) in Biochemistry, Chemistry, or another related science
* Min 5 years experience in QC, method development, validation or stability testing
* Quality Experience with Sterile manufacturing.
* Thorough knowledge of cGMP requirements.
* Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management.
* Good leadership skills and experience in leading project teams
* Strong track record in project management
* Fluent in speaking / writing in English.
In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 64.023,54/year (on a full-time basis).
In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
Are you ready to join us? Then we look forward to your application!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.
If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at jobs.austria@sandoz.com .
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