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. Benefits & Rewards: At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 126,000.00 - 234,000.00 CHF. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. Accessibility and Accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need reasonable accommodation for any part of the recruitment process, or to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.