Novartis
Associate Director, Technical Development(m/w/x)
Vollzeitnur vor OrtSenior
Basel
ab CHF 126.000 - 234.000 / Jahr
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NONovartis Pharma AG
Associate Director, Technical Development(m/w/x)
VollzeitVor OrtSenior
Data Science
Nejo KI-Zusammenfassung
Supporting the local Extractables & Leachables (E&L) Specialty team with strategy development and implementation for late phase assets. Advanced knowledge in E&L and biotechnological CMC development required. Reasonable accommodation for medical condition or disability.
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Anforderungen
- University degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences
- Minimum 5 years in leadership position
- Advanced knowledge in Extractables & Leachables (incl. Analytics/Regulation)
- Advanced knowledge in biotechnological CMC development
- Strong leadership skills and ability to inspire teams
- Make-it-happen spirit
- Solid business acumen
- Align scientific/technical decisions to organizational strategy
- Excellent communication skills
- Excellent interpersonal skills
- Strategic thinking
- High learning agility
- Solution oriented mindset
Aufgaben
- Support the local Extractables & Leachables (E&L) Specialty team
- Contribute to the development of E&L testing and assessment strategies
- Implement E&L testing and assessment strategies
- Align E&L strategies with the global E&L community and wider organization
- Manage Extractables & Leachables activities for late phase assets
- Focus on complex and innovative medicines (AOCs, CGT)
- Guide specialty and cross-functional project teams
- Drive activities within specialty and cross-functional project teams
- Shape risk assessment and analytical strategies
- Develop concepts in line with internal and external regulatory standards
- Drive Data & Digital initiatives within the specialty
- Provide expert support to a team of associates
- Guide the specialty team on technical, scientific, and project management matters
- Act as Subject Matter Expert (SME) for E&L
- Lead relevant initiatives within the broader organization
- Engage with stakeholders and partners
- Manage interfaces with stakeholders and partners
- Coordinate end-to-end project support on E&L activities
- Ensure submission readiness for assigned projects
- Ensure compliance with regulatory requirements
- Apply principles from relevant guidelines (FDA, ICH, USP, ISO)
- Support integration of Data & Digital tools and AI in E&L workflows
- Contribute to Data & Digital and AI initiatives
- Lead Data & Digital and AI initiatives
Berufserfahrung
10 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
Data ScienceProcess SimulationWaterfall Model
Benefits
Sonstige Vorteile
- Relocation support unavailable
- Reasonable accommodation for medical condition or disability
- Inclusion support
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Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharma AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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