As Senior Expert Science & Technology (Analytical Project Lead) 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 Analytical Project Lead you have to ensure that all projects are delivered on time, within scope as well as within budget.

Major accountabilities:

• 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.

Qualifications:

• Degree in Chemistry, Biochemistry, or a related field and at least 8 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)

Preferred Skills:

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

Analytical Project Lead / Senior Expert Science & Technology (m/f/d)