Leading Scientist; m​/f​/d

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your

Key Responsibilities:

Your responsibilities include, but not limited to:

• Independently design, develop, optimize and execute analytical methods for the characterization of biologics (e.g. monoclonal antibodies, biosimilars, ADCs and other complex molecules) using techniques such as HPLC/UHPLC techniques, capillary electrophoresis (CE-SDS, cIEF) and other physicochemical analytical methods.
• Contribute to scientific discussions, investigations and problem-solving activities within the analytical group to support project-related strategic decisions. Interpret analytical results, evaluate data, draw scientifically sound conclusions and review and approve raw data generated by others.
• A main focus of the role will be the coordination and supervision of method development and qualification activities according to state-of-the art method development principles including Design of Experiments (DoE) and method robustness ().
• Skills in techniques as ESI-MS, ion mobility MS, HCP-MS are beneficial for the role.
• Act as a subject matter expert in global work streams supporting strategy development, troubleshooting methods and scientific decision-making
• Participate in global and local digitalization initiatives like LIMS Implementation and drive administration, configuration and continuous improvement of the Chromeleon Chromatography Data System (CDS) to support compliant and efficient analytical laboratory operations.
• Author development reports, study protocols, analytical procedures, method development reports, qualification/pre-validation reports and analytical method handover documents. Contribute to the preparation of regulatory submissions, including the drafting of analytical sections and responses to regulatory authorities, particularly for topics related to structural and physicochemical characterization. Act as a technical expert during audits, inspections and health authority interactions as required.
• Develop and apply scripting/programming solutions (e.g., Python, R or similar tools) to automate, improve and accelerate analytical data processing, evaluation, visualization and statistical analysis
• Conduct literature reviews and scientific assessments, drive knowledge sharing and support the implementation of best practices. Train, mentor and coach scientists and laboratory personnel. Present scientific results internally and externally and contribute to publications, conference presentations, regulatory interactions and intellectual property activities.
• Ensure compliance with Good Documentation Practices data integrity requirements and applicable quality standards. Maintain accurate and complete documentation of analytical activities and ensure adherence to internal procedures and regulatory expectations.

• Minimum:
  Degree with ideally PhD in Bioanalytical Chemistry, Chemistry, Biotechnology, Food Chemistry or other natural sciences and with 3 years of relevant experience in the biopharmaceutical industry; or Master of Science with 6 years relevant experience in the area of instrumental analytics.
• Excellent knowledge in analytical characterization of biopharmaceutical products (proteins, peptides, oligonucleotides, etc.) applying physico-chemical methods, ideally experience on characterization of ADCs.
• Excellent knowledge in Method Development and Method Qualification
• Excellent knowledge of chromatography software (i.e. Chromeleon) and computer…