Director Analytical Characterization

Director Analytical Characterization

Sandoz

Holzkirchen, Germany

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Lead and actively manage the Analytical Characterization department within Biosimilar technical development of Sandoz and drive a culture of exceptional performance and continuous improvement, enabling innovative, competitive, compliant, and consistent delivery on objectives of teams, projects, networks and/or platforms;
• Drive evolution of the team and improve current processes to match evolving landscape and requirements while actively leading that change;
• Provide scientific and managerial leadership to efficiently perform the analytical characterization of Biosimilar candidates;
• Create and implement reliable yet cost efficient methods/processes and procedures - Ensure staying within budget and optimizing resource utilization;
• Ensure adherence to current regulations and data integrity in development;
• Address complex R&D issues and collaborate across technical development line functions. Evaluate and implement new related scientific technologies;
• Build and maintain a highly agile and efficient organization to flexibly react on changing priorities; and
• Understand and meet individual program and customer needs and ensure team activities are aligned with overall biosimilar development processes;
• Drive the Analytical Characterization strategic plan and its implementation. Ensure current and future needs are fully met, adequately resourced, delivered on time and in full compliance.

What you’ll bring to the role:

Essential Requirements:

• Extensive industry experience in the technical/analytical development of Biosimilars;
• Ph.D. Relevant Technical Discipline w/ 10+ yrs. Experience in leading large teams in Analytical Development or adjacent R&D Teams in global technical development organizations;
• Track record in leading change and process improvement initiatives;
• Proven servant leadership skills leading teams through ambiguous times;
• Distinguished R&D leader with exceptionally broad and in-depth knowledge in the area of Analytical Development /Characterization and adjunct disciplines;
• Thorough knowledge of relevant regulations and regulatory guidelines and proven successful track record of BLA submission and regulatory health authority interactions;
• Excellent communication/presentation skills. Advanced coaching and mentoring skills;
• Strategic thinking and ability to lead in a matrix organization;
• English: fluent spoken & written;
• Lean six sigma certification is a plus!