Die KI-Suchmaschine für Jobs
Senior Expert - Medical Device Analytical Representative(m/w/x)
Beschreibung
In this role, you will be at the forefront of developing analytical data packages for drug-device combination products, coordinating project tasks, and collaborating with cross-functional teams to ensure compliance and successful product registrations.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
- •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)
Ausbildung
Berufserfahrung
ca. 4 - 6 Jahre
Aufgaben
- •Lead the creation of analytical data packages for drug-device combination products
- •Coordinate project-specific analytical tasks for functional attributes
- •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 for analytical projects
- •Own drug-specific analytical methods and parameter sheets
- •Organize and align cross-functional inputs for validation and transfer
- •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
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
- Novartis Pharmaceutical Manufacturing GmbHVollzeit/Teilzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau
- Novartis
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert – Analytical Characterization(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrKundl - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau
Senior Expert - Medical Device Analytical Representative(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
In this role, you will be at the forefront of developing analytical data packages for drug-device combination products, coordinating project tasks, and collaborating with cross-functional teams to ensure compliance and successful product registrations.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
- •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)
Ausbildung
Berufserfahrung
ca. 4 - 6 Jahre
Aufgaben
- •Lead the creation of analytical data packages for drug-device combination products
- •Coordinate project-specific analytical tasks for functional attributes
- •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 for analytical projects
- •Own drug-specific analytical methods and parameter sheets
- •Organize and align cross-functional inputs for validation and transfer
- •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
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
Über das Unternehmen
Novartis Pharmaceutical Manufacturing GmbH
Branche
Pharmaceuticals
Beschreibung
The company aims to reimagine medicine to improve and extend people’s lives.
- Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau - Novartis
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert – Analytical Characterization(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrKundl - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorab 65.605,54 / JahrSchaftenau