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Senior Expert - Medical Device Analytical Representative(m/w/x)
Creating data packages for drug-device combination products at a life sciences firm, coordinating outsourced activities at CROs. Master/PhD in engineering/analytics, pharma combination product development experience, and late-phase parenteral knowledge 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
- 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
- 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
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
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbHVollzeit/Teilzeitmit HomeofficeSeniorSchaftenauab 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 – Analytical Characterization(m/w/x)
Vollzeitmit HomeofficeSeniorKundlab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr
Senior Expert - Medical Device Analytical Representative(m/w/x)
Creating data packages for drug-device combination products at a life sciences firm, coordinating outsourced activities at CROs. Master/PhD in engineering/analytics, pharma combination product development experience, and late-phase parenteral knowledge 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
- 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
- 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
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
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
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 – Analytical Characterization(m/w/x)
Vollzeitmit HomeofficeSeniorKundlab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr