Analytical Project Lead (m/f/d)

Your Key Responsibilities: You are responsible for the overall analytical project strategy including robust and phase-dependent control strategy to support technical development of highly innovative biologic products. You will lead and coordinate the analytical sub-team in a matrix organization and represent the analytic discipline in the global CMC project team of assigned projects. You are accountable for managing all analytic related activities of drug product and drug substance development including release and stability testing, molecule characterization, method-development, -transfer and -validation, specification setting, know-how transfer etc. You will lead and coordinate timely delivery of high quality source documents for submission, review of regulatory documents and interact with Health Authorities in audits and scientific advice meetings. You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc. You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level. You are responsible for high quality analytical registration documents for HA submissions and interact with authorities, act as technical expert in audits, inspections etc. You are responsible for analytical budget and resource planning. Minimum requirements: PhD and minimum of 8 years relevant experience of Biologics CMC development or University life-science degree with appropriate industry experience. Excellent theoretical and profound scientific knowledge in analytical areas in biologic drug development. Strong scientific leadership, bringing innovative molecules from research to development. Excellent understanding of regulatory expectations and requirements with significant experience with IND/BLA submission. Strong experience in leading matrix teams and strong communication skills. Proficiency in English.