#LI-Hybrid Location: Basel, Switzerland
This role is based in Basel, Switzerland. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Responsibilities
Overall analytical project strategy including robust and phase-dependent control strategy to support technical development of highly innovative biologic products. 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. 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. 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. Communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc. Proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level. Responsible for high quality analytical registration documents for HA submissions and interact with authorities, act as technical expert in audits, inspections etc. 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. 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 is reviewed periodically. May be eligible for a performance-based bonus depending on certain performance parameters. Competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. 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. 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 diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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This role is based in Basel, Switzerland. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Responsibilities
Overall analytical project strategy including robust and phase-dependent control strategy to support technical development of highly innovative biologic products. 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. 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. 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. Communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc. Proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level. Responsible for high quality analytical registration documents for HA submissions and interact with authorities, act as technical expert in audits, inspections etc. 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. 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 is reviewed periodically. May be eligible for a performance-based bonus depending on certain performance parameters. Competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. 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. 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 diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Analytical Project Lead (m/f/d) Arbeitgeber: Novartis Farmacéutica
Novartis Farmacéutica ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Basel, Schweiz, eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Innovation und Zusammenarbeit fördert das Unternehmen die persönliche und berufliche Weiterentwicklung seiner Mitarbeiter durch umfassende Schulungsprogramme und spannende Projekte im Bereich Life Sciences und KI. Die attraktiven Vergütungen und umfangreichen Sozialleistungen machen Novartis zu einem idealen Ort für Fachkräfte, die einen bedeutenden Beitrag zur Gesundheitsversorgung leisten möchten.
