Scientist - Sandoz Product Development

Scientist - Sandoz Product Development

Sandoz

Rudolstadt, Germany

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Planning, execution and evaluation of scientific studies with focus on in-vitro bioequivalence and development studies in the context of the pharmaceutical development of respiratory combination product from early stage up to pilot scale;
• Act as core member of the technical project team;
• Coordination of development work with internal and external development partners;
• Ensure compliance with Regulatory and Quality requirements for technical product development in accordance with internal, national and international guidelines (GMP, ICH, etc.) in order to guarantee successful approval of the respiratory combination product;
• Assess and consolidate with the project leader and other key stakeholders all resource needs needed and timelines for assigned projects;
• Use the possibilities offered by modern formulation, process and analytical technologies to progress projects in a timely manner.

What you’ll bring to the role:

• Minimal BSc degree (PhD preferred) in Chemistry, Pharmacy, or related field or at least 6 years of relevant work-related experience in respiratory combination product development;
• Understanding of Quality-By-Design and product development lifecycle;
• Knowledge of in-vitro tests for characterization of Dry Powder Inhaler and of statistical methods relevant for bioequivalence evaluations, Python and R-programming skills would be a plus;
• Basic knowledge of relevant guidelines and literature within the above-mentioned field of responsibilities with excellent knowledge in GMP and qualification standards;
• Fluent in spoken and written English and ideally in German;
• Presentation skills to communicate effectively to peers and senior management, with the scientific writing skills to complete Regulatory submission documentation;
• You are a team player, work independently and are result-orientated.

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