Principal Scientist - Analytical Project Lead

Principal Scientist - Analytical Project Lead

Sandoz

Holzkirchen, Germany

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Lead, manage and scientifically oversee all analytical tasks in biosimilar projects; coordinate and lead the analytical sub-team, ensuring alignment with organizational goals and development functions; and further, represent Analytical Development in global, multifunctional CMC project teams.
• Drive and develop analytical project strategies and plans, including timelines, milestones, decision, and ensuring lean development and lean project execution. Characterization of the API, method-development (fit for purpose and robust), transfer and -validation, specification setting, release and stability testing, know-how transfer, etc.
• Coordinate and compile high quality analytical registration documents for HA submissions and, interact with Health Authorities where appropriate; act as technical expert in audits, inspections.
• Ensure integrity of data and compliance with regulatory guidelines and industry standards and interpret results within relevant context, drawing the right conclusions.
• Provide scientific and technical guidance, actively drive knowledge exchange.
• Develop, mentor and coach principal scientists and other scientific associates.
• Identify, mitigate and manage analytical project risks.

What you’ll bring to the role:

Essential Requirements:

• Higher Degree in Chemistry, Biochemistry, or a related field and minimum of 6 years relevant experience in the bio-/pharmaceutical industry.
• Track record and broad knowledge in analytical / technical development of biosimilars including Health authority interactions, (IND/IMPD/CTA/BLA preparations and submissions).
• Strong communication, interpersonal and problem-solving skills.
• Excellent organizational and leadership skills.
• Good sense for innovation, strategic thinking und open minded personality.
• Proficient scientific/technical writing skills and excellent presentation skills.
• Fluent in English (oral and written).