AS&T Manager , Large Molecules

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Acts as Single Point of Contact (SPOC) for all AS&T related activities at the External Suppliers, specifically for the Biosimilars family.
• Lead and implement 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.
• Lead and own analytical method transfers (AMTs) process within ESO Injectables function. Support the external suppliers’ selection process, qualification process and analytical trouble shooting as needed.
• Support the regulatory team in submissions, variations and other regulatory activities from an analytical perspective. Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
• Support Quality Assurance Manager (QAM) to define and maintain the ESO Stability Program at CMOs and ensure that Stability Programs are state-of-the-art with respect to HA requirements and in line with registration documentation.
• Support interpreting stability data, trends and provide scientifically sound conclusions for product shelf-life assessments, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
• Support QAM in analytical results investigations (e.g. OOS), complaints that require analytical interpretation. Support defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply. Support the QAM in product investigations and assure that they are managed in agreement with Sandoz standards.
• Responsible for implementing effective CAPAs at the suppliers/contract labs. Support QAM to ensure Testing Monographs are state-of-the-art with respect to technique and technology and in line with registration documentation.
• Responsible SPOC for implementation of compliance alerts for analytical methods / monographs. Provide support for site readiness for Health Authority inspections as required. Participate in audits/technical visits on request as an SME.
  
  

Essential Requirements

What you’ll bring to the role:

Education

• Higher University Degree (e.g. Masters or Ph D) in Natural Sciences (Chemistry, Pharmacy, Biotechnology, Biology)
• Performance against established Key Quality Indicators.
• Experience:
• 10 or more years’ experience in QC or analytical development that includes method development, method validation, stability testing, method transfers.
• Expertise in different analytical techniques required for Biosimilars and Biologics.
• Thorough knowledge of cGMP requirements, ICH guidelines, Major Pharmacopeial requirements, regulatory requirements.
  
  

Leadership Skills

• Strong communication skills.
• Strong track record in project management.
• Efficient management of internal and external stakeholders.
• Ability to work independently in a matrix organization / set-up.
• Ability to drive performance improvement initiatives / transformation.
• Open to adapt with new work environment and working in different time zones.
  
  

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, 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 is 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 supported!

Join us!