Lead Extractables & Leachables Scientist

Novartis; Österreich; Hybrid; EUR 61.000 - 96.000; Vollzeit

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

14 weeks paid parental leave

Zusammenfassung

Novartis in Schaftenau, Austria, seeks an Expert Science & Technology (Extractables and Leachables) to lead complex E&L strategies across drug development. You will collaborate with global teams, interpret analytical data, and drive regulatory-ready documentation to support high-quality medicines.

The role blends analytical science, materials science, and regulatory innovation. The position emphasizes leadership of studies, scientific writing, and cross-functional collaboration in a regulated

Qualifikationen

• Advanced degree in Pharmacy, Chemistry, Life Sciences or related field.
• Strong expertise in Extractables and Leachables assessment within a regulated environment.
• Hands-on experience with chromatographic and mass spectrometry analytical techniques.
• Proven ability to lead complex scientific projects and manage multiple priorities.
• Excellent scientific writing with experience in technical and regulatory documentation.
• Strong communication and collaboration across multidisciplinary teams.

Aufgaben

• Lead Extractables and Leachables strategies and risk assessments across complex drug development projects.
• Serve as the scientific expert and primary contact for multidisciplinary project teams.
• Design and oversee Extractables and Leachables studies with internal laboratories and external partners.
• Interpret analytical data, identify trends, and provide scientifically sound recommendations.
• Author and review technical documentation, assessments, and regulatory submission content.
• Drive cross-functional collaboration to solve complex scientific and operational challenges.
• Lead continuous improvement initiatives that enhance testing approaches, workflows, and risk assessment strategies.

Kenntnisse

Extractables & Leachables

Chromatography

Mass spectrometry

Regulatory documentation

Project leadership

Scientific writing

Communication

Ausbildung

Advanced degree in Pharmacy, Chemistry, Life Sciences

Jobbeschreibung

Novartis in Schaftenau, Austria, seeks an Expert Science & Technology (Extractables and Leachables) to lead complex E&L strategies across drug development. You will collaborate with global teams, interpret analytical data, and drive regulatory-ready documentation to support high-quality medicines.

The role blends analytical science, materials science, and regulatory innovation. The position emphasizes leadership of studies, scientific writing, and cross-functional collaboration in a regulated