Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Vollzeitnur vor OrtManagement
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, TeilzeitVor OrtSenior
Data Science
Nejo KI-Zusammenfassung
Leading biologics formulation and process development for complex drug products. 8+ years industry experience with QbD and tech transfers required. Attractive incentive program, modern pension scheme.
Anforderungen
- Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
- Minimum 8 years relevant industry experience
- Focus on drug product formulation and process development
- Experience in technology transfers and regulatory submissions
- Proficient in quality principles, Quality by Design (QbD)
- Proficient in Good Manufacturing Practice (GMP)
- Proficient in regulatory requirements
- Experience in Investigational New Drug (IND) / Biologics License Application (BLA) submissions
- Excellent leadership skills
- Excellent interdisciplinary skills
- Track record of leading cross-functional global teams
- Track record of leading cross-functional global 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 Artificial Intelligence (AI)-driven solutions
- Strategic mindset
- Strong business acumen
- Responsible professional
- Objective-driven professional
- Resilient professional
- Thrives in collaborative, cross-functional environments
- Eager to embrace new challenges
- Eager to expand expertise
Aufgaben
- Lead technical development strategy for complex 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, briefing books)
- Interact with Health Authorities
- Set priorities for the drug product sub-team
- Communicate project strategy and requirements
- Engage stakeholders across CMC teams
- Engage stakeholders across sub-teams
- Engage stakeholders across line functions
- Engage stakeholders across internal/external partners
- Assess resource needs
- Assess project budget needs
- Strategically evaluate external assets for development
- Integrate external assets for development
Berufserfahrung
- 8 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Quality by Design (QbD)
- Good Manufacturing Practice (GMP)
- Investigational New Drug (IND)
- Biologics License Application (BLA)
- Artificial Intelligence (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, TeilzeitVor OrtSenior
Data Science
Nejo KI-Zusammenfassung
Leading biologics formulation and process development for complex drug products. 8+ years industry experience with QbD and tech transfers required. Attractive incentive program, modern pension scheme.
Anforderungen
- Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
- Minimum 8 years relevant industry experience
- Focus on drug product formulation and process development
- Experience in technology transfers and regulatory submissions
- Proficient in quality principles, Quality by Design (QbD)
- Proficient in Good Manufacturing Practice (GMP)
- Proficient in regulatory requirements
- Experience in Investigational New Drug (IND) / Biologics License Application (BLA) submissions
- Excellent leadership skills
- Excellent interdisciplinary skills
- Track record of leading cross-functional global teams
- Track record of leading cross-functional global 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 Artificial Intelligence (AI)-driven solutions
- Strategic mindset
- Strong business acumen
- Responsible professional
- Objective-driven professional
- Resilient professional
- Thrives in collaborative, cross-functional environments
- Eager to embrace new challenges
- Eager to expand expertise
Aufgaben
- Lead technical development strategy for complex 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, briefing books)
- Interact with Health Authorities
- Set priorities for the drug product sub-team
- Communicate project strategy and requirements
- Engage stakeholders across CMC teams
- Engage stakeholders across sub-teams
- Engage stakeholders across line functions
- Engage stakeholders across internal/external partners
- Assess resource needs
- Assess project budget needs
- Strategically evaluate external assets for development
- Integrate external assets for development
Berufserfahrung
- 8 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Quality by Design (QbD)
- Good Manufacturing Practice (GMP)
- Investigational New Drug (IND)
- Biologics License Application (BLA)
- Artificial Intelligence (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
Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Vollzeitnur vor OrtManagementSchaftenauab 65.605,54 / Jahr - Novartis
Director Science & Technology - Scientific Office DS(m/w/x)
Vollzeitnur vor OrtManagementBasel, Schaftenauab 85.704,64 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Technical Transfer Lead, Medical Device(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Technical Transfer Lead(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Quality Team Leader QC(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 78.383,9 / Jahr