Senior Expert Science & Technology (AC) (m/f/d)

at  Sandoz

As Senior Expert Science & Technology you will oversee and drive all analytical aspects in Biosimilar development projects from inception to completion. This role requires a strong background in analytical methodologies, project management, technical development and team leadership. Furthermore, as Senior Expert Science & Technology you have to ensure that all projects are delivered on time, within scope as well as within budget.

Essential Requirements:

• Degree in Chemistry, Biochemistry, or a related field and at least 6 years relevant experience in the biopharmaceutical industry. A Master’s or Ph.D. is preferred.
• Proven experience in analytical project management. Broad theoretical and scientific knowledge in other areas (e.g. biotech manufacturing, pharmaceutical).
• Strong communication and interpersonal skills.
• Strong knowledge of analytical techniques and methodologies.
• Excellent organizational and leadership skills.
• Good sense for innovation, strategic thinking und open minded personality.
• Fluent in English (oral and written

Desirable Requirements:

• Experience in the pharmaceutical or biotechnology industry.
• Knowledge of regulatory requirements (e.g., FDA, EMA).
• Proficient scientific/technical writing skills and excellent presentation skills.
• Aim for eight bullet point

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

• Lead and manage analytical tasks in biosimilar projects, coordinate the analytical sub-team functions, ensuring alignment with organizational goals.
• Represent Analytical Development in global, multifunctional CMC project teams of assigned projects.
• Develop project plans, including timelines, milestones, and resource allocation (incl. budget planning for assigned projects). In particular, design, plan, supervise and monitor all analytical activities of assigned teams/projects (including characterization of the API, method-development, -transfer and -validation, specification setting, release and stability testing, know-how transfer, etc)
• Coordinate international, cross-functional teams to ensure seamless project execution. Work closely with internal and external project partners.
• Coordinate and compile high quality analytical registration documents for HA submissions and, potentially, write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits, inspections.
• Ensure compliance with regulatory requirements/guidelines and industry standards.
• Identify and mitigate project risks.
• Foster a collaborative and high-performance team environment.
• Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share within the team.
• Provide scientific and technical guidance, actively drive knowledge exchange. Develop, mentor and coach principal scientists and other scientific associates.

WHAT YOU’LL BRING TO THE ROLE:

Essential Requirements:

• Degree in Chemistry, Biochemistry, or a related field and at least 6 years relevant experience in the biopharmaceutical industry. A Master’s or Ph.D. is preferred.
• Proven experience in analytical project management. Broad theoretical and scientific knowledge in other areas (e.g. biotech manufacturing, pharmaceutical).
• Strong communication and interpersonal skills.
• Strong knowledge of analytical techniques and methodologies.
• Excellent organizational and leadership skills.
• Good sense for innovation, strategic thinking und open minded personality.
• Fluent in English (oral and written)

Desirable Requirements:

• Experience in the pharmaceutical or biotechnology industry.
• Knowledge of regulatory requirements (e.g., FDA, EMA).
• Proficient scientific/technical writing skills and excellent presentation skills.
• Aim for eight bullet points