Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSenior
Schaftenau
ab 65.605,54 / Jahr
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NONovartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeit, Teilzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading analytical data package creation for drug-device combination products, coordinating outsourced analytical projects with CROs. Proven knowledge in late phase parenteral analytical development and leadership experience in global matrix projects required. On-site childcare facilities.
Anforderungen
- Master or PhD in engineering, chemical/bio analytics, or equivalent
- Some working experience in pharmaceutical industry in combination product development
- Proven knowledge in late phase parenteral analytical development
- Leadership experience in managing development projects in a global matrix environment
- Understanding and awareness of regulatory guidelines for combination product analytics
- Experience with cGMP and relevant ISOs
- Collaborative spirit
- Self-driven attitude
- High level of learning agility
- Proficiency in English (written and spoken)
Aufgaben
- Lead the creation of analytical data packages for drug-device combination products
- Coordinate project-specific analytical tasks for functional attributes at all levels
- Plan resources and budget for projects
- Select testing laboratories based on resource availability and capabilities
- Lead outsourced analytical project activities at CROs
- Manage external partnerships effectively
- Own and document drug-specific analytical methods and parameter sheets
- Organize and align cross-functional inputs with Device/Pack Tech
- Define and validate analytical methods and parameter sheets
- Co-author cross-functional analytical CMC strategies and documents
- Organize input for Justification of Specification from Device/Pack Tech and HFE
- Contribute to and review regulatory documents for product registrations
- Support product registrations and present at inspections with minimal support
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Market-competitive base salary
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
Senior Expert - Medical Device Analytical Representative(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeit, Teilzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading analytical data package creation for drug-device combination products, coordinating outsourced analytical projects with CROs. Proven knowledge in late phase parenteral analytical development and leadership experience in global matrix projects required. On-site childcare facilities.
Anforderungen
- Master or PhD in engineering, chemical/bio analytics, or equivalent
- Some working experience in pharmaceutical industry in combination product development
- Proven knowledge in late phase parenteral analytical development
- Leadership experience in managing development projects in a global matrix environment
- Understanding and awareness of regulatory guidelines for combination product analytics
- Experience with cGMP and relevant ISOs
- Collaborative spirit
- Self-driven attitude
- High level of learning agility
- Proficiency in English (written and spoken)
Aufgaben
- Lead the creation of analytical data packages for drug-device combination products
- Coordinate project-specific analytical tasks for functional attributes at all levels
- Plan resources and budget for projects
- Select testing laboratories based on resource availability and capabilities
- Lead outsourced analytical project activities at CROs
- Manage external partnerships effectively
- Own and document drug-specific analytical methods and parameter sheets
- Organize and align cross-functional inputs with Device/Pack Tech
- Define and validate analytical methods and parameter sheets
- Co-author cross-functional analytical CMC strategies and documents
- Organize input for Justification of Specification from Device/Pack Tech and HFE
- Contribute to and review regulatory documents for product registrations
- Support product registrations and present at inspections with minimal support
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Market-competitive base salary
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.
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 - Medical Device Analytical Representative(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert – Analytical Characterization(m/w/x)
Vollzeitmit HomeofficeSeniorKundlab 65.605,54 / Jahr - Novartis
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr