Senior Expert, Medical Device Analytics & CMC

Novartis; Österreich; Hybrid; EUR 71.000 - 86.000; Vollzeit

Benefits dieser Stelle

Pension scheme

Career development

Worldwide opportunities

Zusammenfassung

Novartis in Schaftenau, Austria, seeks a Senior Expert - Medical Device Analytical Representative to lead analytical data packages for drug-device combination products. You will coordinate global CMC analytical tasks, manage labs, and drive strategies for activation, injection force, and safety features in injectables.

Requires a Master/PhD and 5+ years in parenteral development, strong regulatory knowledge, and English proficiency.

Qualifikationen

• Master or PhD in engineering or chemical/bio analytics or equivalent.
• Minimum 5 years’ experience in parenteral combination product development.
• Leadership in development projects within a global matrix environment.
• Knowledge of cGMP and ISO for combination product analytics.
• Proficiency in English (written and spoken).

Aufgaben

• Coordinate analytical tasks for functional attributes across components, drug product and final product; plan resources and budget.
• Select testing laboratories and lead outsourced analytical activities at CROs; manage external partnerships.
• Own drug-specific analytical methods and parameter sheets for attributes like activation and injection force; document validation/transfer.
• Co-author analytical CMC strategies and documents; contribute to Justification of Specification (JoS).
• Support regulatory documents and product registrations under leadership; perform statistical data analysis (e.g., Minitab).

Kenntnisse

Parenteral analytics

Project leadership

Regulatory knowledge

Analytical chemistry

English proficiency

Ausbildung

Master's or PhD in engineering

Chemical/Bio analytics

Tools

Minitab

Jobbeschreibung

Novartis in Schaftenau, Austria, seeks a Senior Expert - Medical Device Analytical Representative to lead analytical data packages for drug-device combination products. You will coordinate global CMC analytical tasks, manage labs, and drive strategies for activation, injection force, and safety features in injectables.

Requires a Master/PhD and 5+ years in parenteral development, strong regulatory knowledge, and English proficiency.