Associate Director, E&L Strategy & Leadership

Novartis; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Novartis in Basel, Switzerland seeks an Associate Director for the Extractables & Leachables (E&L) Specialty within PAS. You will lead a small team, guide E&L testing strategies for late-phase assets, and align with global E&L standards in a multidisciplinary setting.

You will shape risk assessments, develop analytical concepts, and drive Data & Digital initiatives in E&L while collaborating with DS/DP development and MS&T. A PhD and 10+ years in pharma with 5+ years in leadership are preferred.

Qualifikationen

• PhD in a relevant science field (Pharmacy/Biotech/Life Sciences).
• 10+ years in pharma industry.
• 5+ years in leadership leading teams.
• Advanced knowledge of E&L and biotech CMC.
• Strong leadership and communication skills.

Aufgaben

• Provide SME support to a team of associates and E&L experts.
• Guide the team in alignment with strategies and regulatory requirements.
• Lead initiatives within the broader organization as SME for E&L.
• Engage with stakeholders across DS/DP development, MS&T, toxicology.
• Coordinate end-to-end project support and ensure submission readiness.
• Ensure compliance with FDA/ICH/USP/ISO guidelines.
• Support integration of Data & Digital tools and AI in E&L workflows.

Kenntnisse

Leadership

E&L Expertise

Regulatory Knowledge

Project Management

Strategic Thinking

Stakeholder Engagement

Biotech CMC

Ausbildung

PhD in Pharmacy/Life Sciences

Jobbeschreibung

Novartis in Basel, Switzerland seeks an Associate Director for the Extractables & Leachables (E&L) Specialty within PAS. You will lead a small team, guide E&L testing strategies for late-phase assets, and align with global E&L standards in a multidisciplinary setting.

You will shape risk assessments, develop analytical concepts, and drive Data & Digital initiatives in E&L while collaborating with DS/DP development and MS&T. A PhD and 10+ years in pharma with 5+ years in leadership are preferred.