Senior GMP Analytics Scientist, Biologics

Novartis; Schweiz; Vor Ort; EUR 67.000 - 118.000; Vollzeit

Zusammenfassung

Novartis in Schaftenau, Austria is seeking a Senior Expert Science & Technology to lead GMP analytical activities within Analytical Operations for biologics projects in clinical development. You will drive method transfer, validation, release testing, and documentation with a global team.

You will oversee data interpretation, ensure GMP compliance, and collaborate across labs and functions, leveraging digital tools to accelerate development and maintain high quality standards.

Qualifikationen

• Master's degree in biotech/chemistry or related field with 7+ years of industry experience.
• Proven experience with analytical methods in biotech/pharma settings.
• Strong GMP knowledge and regulatory awareness for analytical development.
• Excellent scientific writing and submission-ready documentation skills.
• Fluent in English, with strong verbal and written communication.
• Ability to lead cross-functional teams in a matrix environment.
• Strong digital fluency and data-driven mindset.

Aufgaben

• Provide scientific guidance and lead GMP-related analytical activities within global project analytical sub-teams for assigned clinical development projects.
• Manage release, stability studies, validation, transfer, and implementation of analytical methods per GMP and timelines.
• Design, supervise, and coordinate analytical activities while managing multiple priorities, customer needs, timelines, and resource requirements.
• Author, review, and approve high-quality scientific and GMP documentation such as protocols, reports, laboratory procedures, test records, release and stability documents, transfer reports, and submission-relevant documentation.
• Evaluate analytical data, interpret results, draw scientifically sound conclusions, and critically review data generated by others.
• Investigate and support resolution of quality events within projects, including deviations, changes, and out-of-specification events.
• Support laboratory teams in troubleshooting analytical methods and processes and solving complex scientific or technical challenges.
• Contribute to budget and resource forecasts, ensure cost awareness, and proactively manage project deliverables and timelines.
• Drive knowledge sharing, present scientific results across the organization, and contribute to continuous improvement and optimization of work processes.
• Ensure all activities comply with GMP, HSE, and applicable Novartis quality standards.

Kenntnisse

GMP knowledge

Analytical methods expertise

HPLC/CE methods

Scientific writing

English proficiency

Cross-functional collaboration

Digital fluency

Ausbildung

Master's degree in biotech/chemistry or related

PhD in a related field (optional)

Tools

HPLC

CE

Jobbeschreibung

Novartis in Schaftenau, Austria is seeking a Senior Expert Science & Technology to lead GMP analytical activities within Analytical Operations for biologics projects in clinical development. You will drive method transfer, validation, release testing, and documentation with a global team.

You will oversee data interpretation, ensure GMP compliance, and collaborate across labs and functions, leveraging digital tools to accelerate development and maintain high quality standards.