Novartis Pharma AG
Associate Director, Technical Development(m/w/x)
Vollzeitnur vor OrtSenior
Basel
ab CHF 126.000 - 234.000 / Jahr
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NONovartis
Associate Director, Technical Development(m/w/x)
VollzeitVor OrtSenior
Data Science
Nejo KI-Zusammenfassung
Managing Extractables & Leachables activities for late phase assets at a global pharmaceutical company. Advanced knowledge in E&L and biotechnological CMC development required. Commitment to diversity and inclusion, reasonable accommodation for recruitment process.
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Anforderungen
- University degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences or relevant science discipline
- Minimum 10 years pharmaceutical industry experience
- Minimum 5 years leadership experience with successful team leadership
- Advanced knowledge in Extractables & Leachables (incl. Analytics/Regulation)
- Advanced knowledge in biotechnological CMC development
- Strong leadership skills, ability to lead and inspire scientists
- Make-it-happen spirit
- Solid business acumen, aligning scientific decisions to strategy
- Excellent communication and 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 recruitment process
Lockere Unternehmenskultur
- Commitment to diversity and inclusion
Mentale Gesundheitsförderung
- Support for individuals with medical condition or disability
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PharmaceuticalsBasel
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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