Analytical Project Lead (m/f/d)

#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
• Ph D 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:
• 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 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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