Senior Expert Science and Technology/Principle Scientist

Senior Expert Science and Technology/Principle Scientist

Sandoz

Holzkirchen, Germany

Role Overview

As Senior Expert Science and Technology in Analytical Characterization, you will lead and execute advanced analytical strategies for biosimilar development. Your expertise ensures robust characterization of active pharmaceutical ingredients (API) and compliance with global regulatory standards.

Key Responsibilities

• Design, plan, and oversee analytical characterization activities for biosimilars (incl. method development, transfer, validation, specification setting, release and stability testing);
• Act as subject matter expert in global CMC project teams, representing Analytical Development;
• Prepare and review analytical documentation for regulatory submissions; support audits and inspections;
• Ensure data integrity and interpret results within scientific and regulatory context;
• Drive innovation in analytical methodologies and foster knowledge exchange;
• Mentor and coach scientific associates and principal scientists.

Qualifications

• Degree in Chemistry, Biochemistry, or related field; Master’s or Ph.D. preferred;
• Minimum 6 years of relevant experience in biopharmaceutical industry;
• Deep expertise in analytical characterization and project management;
• Strong communication, leadership, and organizational skills;
• Fluent in English (oral and written).

Preferred Skills

• Experience with regulatory requirements (FDA, EMA);
• Strong scientific writing and presentation skills.