Novartis Pharmaceutical Manufacturing GmbH
Scientist in Drug Product Development, Senior Expert Science & Technology(m/w/x)
Vollzeitmit HomeofficeSenior
Schaftenau
ab 65.605,54 / Jahr
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NONovartis Pharmaceutical Manufacturing GmbH
Drug Product Project Leader – Associate Director Science & Technology(m/w/x)
Schaftenau
ab 78.383,9 / Jahr
Vollzeit, Teilzeitmit HomeofficeSenior
Data Science
Nejo KI-Zusammenfassung
Leading biologics formulation and process development for IND/BLA submissions. Ph.D. and 8+ years industry experience required. Worldwide career possibilities, childcare facilities.
Anforderungen
- Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
- Minimum 8 years relevant industry experience
- Proficiency in quality principles, QbD, GMP, regulatory requirements
- Experience in IND/BLA submissions
- Excellent leadership skills
- Interdisciplinary skills
- Track record of leading cross-functional global teams
- Track record of leading projects
- Excellent project management skills
- Excellent communication/presentation skills
- Excellent stakeholder management skills
- Excellent scientific/technical writing skills
- Openness to digital transformation
- Proactiveness in adopting new digital tools
- Proactiveness in adopting AI-driven solutions
- Strategic mindset
- Strong business acumen
- Responsible professional
- Objective-driven professional
- Resilient professional
- Thrives in collaborative environments
- Thrives in cross-functional environments
- Eager to embrace new challenges
- Eager to expand expertise
- Budget Management
- Coaching Skills
- Data Science
- Experiments Design
- Laboratory
- Problem Solving Skills
- Process Simulation
- R&D
- Waterfall Model
Aufgaben
- Lead technical development strategy for biologics
- Represent Drug Product Development in CMC teams
- Ensure delivery of agreed milestones
- Champion scientific excellence in drug product formulation
- Champion scientific excellence in process development
- Champion scientific excellence in technical transfers
- Champion scientific excellence in process validation
- Champion scientific excellence in product registration
- Lead global drug product sub-team
- Coordinate global drug product sub-team
- Foster sub-team member growth through coaching
- Be accountable for timely source document delivery
- Review regulatory documents (CMC modules)
- Review regulatory documents (briefing books)
- Interact with Health Authorities
- Respond to Health Authority information requests
- Manage Health Authority inspections
- Set priorities for the drug product sub-team
- Communicate overall project strategy
- Communicate project requirements
- Ensure effective stakeholder engagement
- Assess resource needs
- Consolidate resource needs
- Assess project budget needs
- Consolidate project budget needs
- Strategically evaluate external assets
- Integrate external assets for development
- Align external assets with portfolio strategy
Berufserfahrung
- 8 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- IND
- BLA
- AI
Benefits
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development opportunities
Karriere- und Weiterentwicklung
- Worldwide career possibilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH 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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NONovartis Pharmaceutical Manufacturing GmbH
Drug Product Project Leader – Associate Director Science & Technology(m/w/x)
Schaftenau
ab 78.383,9 / Jahr
Vollzeit, Teilzeitmit HomeofficeSenior
Data Science
Nejo KI-Zusammenfassung
Leading biologics formulation and process development for IND/BLA submissions. Ph.D. and 8+ years industry experience required. Worldwide career possibilities, childcare facilities.
Anforderungen
- Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
- Minimum 8 years relevant industry experience
- Proficiency in quality principles, QbD, GMP, regulatory requirements
- Experience in IND/BLA submissions
- Excellent leadership skills
- Interdisciplinary skills
- Track record of leading cross-functional global teams
- Track record of leading projects
- Excellent project management skills
- Excellent communication/presentation skills
- Excellent stakeholder management skills
- Excellent scientific/technical writing skills
- Openness to digital transformation
- Proactiveness in adopting new digital tools
- Proactiveness in adopting AI-driven solutions
- Strategic mindset
- Strong business acumen
- Responsible professional
- Objective-driven professional
- Resilient professional
- Thrives in collaborative environments
- Thrives in cross-functional environments
- Eager to embrace new challenges
- Eager to expand expertise
- Budget Management
- Coaching Skills
- Data Science
- Experiments Design
- Laboratory
- Problem Solving Skills
- Process Simulation
- R&D
- Waterfall Model
Aufgaben
- Lead technical development strategy for biologics
- Represent Drug Product Development in CMC teams
- Ensure delivery of agreed milestones
- Champion scientific excellence in drug product formulation
- Champion scientific excellence in process development
- Champion scientific excellence in technical transfers
- Champion scientific excellence in process validation
- Champion scientific excellence in product registration
- Lead global drug product sub-team
- Coordinate global drug product sub-team
- Foster sub-team member growth through coaching
- Be accountable for timely source document delivery
- Review regulatory documents (CMC modules)
- Review regulatory documents (briefing books)
- Interact with Health Authorities
- Respond to Health Authority information requests
- Manage Health Authority inspections
- Set priorities for the drug product sub-team
- Communicate overall project strategy
- Communicate project requirements
- Ensure effective stakeholder engagement
- Assess resource needs
- Consolidate resource needs
- Assess project budget needs
- Consolidate project budget needs
- Strategically evaluate external assets
- Integrate external assets for development
- Align external assets with portfolio strategy
Berufserfahrung
- 8 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- IND
- BLA
- AI
Benefits
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development opportunities
Karriere- und Weiterentwicklung
- Worldwide career possibilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Novartis Pharmaceutical Manufacturing GmbH
Branche
Pharmaceuticals
Beschreibung
The company aims to reimagine medicine to improve and extend people’s lives.
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbH
Scientist in Drug Product Development, Senior Expert Science & Technology(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Scientist in Drug Product Development, Senior Expert Science & Technology(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Director Technical Project Portfolio Management(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 85.704,64 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Director Technical Project Portfolio Management(m/w/x)
Vollzeitmit HomeofficeManagementSchaftenauab 85.704,64 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr