Analytical Project Lead; m​/f​/d

Summary

Location:

Basel, Switzerland.

Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

We are a global team of highly skilled analytical project managers present in all biologics technical research and development sites of Novartis in Europe, and we are looking for an experienced, curious, and inspiring Analytical Project Leader to join our team in Basel to support the development of biologic products.

• 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, and know‑how transfer.
• Lead and coordinate timely delivery of high quality source documents for submission; review of regulatory documents and interaction with health authorities in audits and scientific advice meetings.
• Communicate effectively across organizational interfaces such as 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 interaction with authorities; act as technical expert in audits and inspections.
• Responsible for analytical budget and resource planning.

• PhD and minimum of 8 years relevant experience in Biologics CMC development or a 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.

Expected Annual Base Salary Range for role: 126,000 – 234,000 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. Upon joining Novartis, the salary will be reviewed periodically.

In addition to the base salary, you may be eligible for a performance‑based bonus depending on certain performance parameters.

Additional benefits include:

• Insurance plans and retirement plans.
• Well‑being resources and global recognition programs.
• Flexible and hybrid working options, where possible.
• Minimum 14 weeks paid parental leave.

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 divers and let us know the nature of your request and your contact information.

Please include the job requisition number in your message.

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.