Senior Expert Science & Technology (Analytical Operations)

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

Salary Range

€66,918.00 - €117,800.00

Job Description Summary

Location: Schaftenau, Austria #onsite

Role Purpose

As a Senior Expert Science & Technology, you will join Analytical Operations within Technical Research and Development Biologics and contribute to the development of innovative biologic medicines for patients in clinical trials. In this role, you will act as a GMP Analytical Expert, representing the analytical function in global project analytical sub-teams and ensuring timely, compliant, and scientifically sound support for clinical development projects.

You will coordinate and drive GMP-related analytical activities including release testing, stability studies, validation, transfer and implementation of analytical methods, as well as preparation of high-quality scientific and regulatory documentation. The role combines scientific leadership, project coordination, documentation ownership, and close collaboration with laboratory teams and cross-functional partners.

All roles operate with a Future-Ready/Digital First mindset: leveraging data, digital tools, and emerging technologies to improve decision-making, accelerate development, and maintain compliance. Associates are expected to build digital fluency, innovate responsibly, learn continuously, and collaborate across functions.

Job Description

Key Responsibilities

• Provide scientific guidance and lead GMP-related analytical activities within global project analytical sub-teams for assigned clinical development projects.
• Independently manage key project tasks including release, stability studies, validation, transfer, and implementation of analytical methods according to GMP standards and agreed project 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.

Essential Requirements

• Master's degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry, pharmaceutical technology, chemical engineering, or a related scientific discipline with at least 7 years of relevant industry experience; or PhD in a relevant field with at least 4 years of relevant industry experience.
• Proven experience with analytical methods in an industrial or pharmaceutical setting, preferably within biotechnology or biologics development.
• Strong knowledge of GMP standards, regulations, and quality expectations in analytical development, QC, or a comparable environment.
• Good theoretical and scientific expertise in relevant analytical technologies such as HPLC, CE, biochemical methods, or comparable techniques.
• Excellent scientific and technical writing skills, with the ability to prepare clear, submission-ready documentation.
• Strong proficiency in oral and written English, including effective presentation skills.
• Demonstrated collaboration and communication skills, with the ability to work effectively across functions and organizational interfaces.
• Ability to lead and contribute to cross-functional teams in a matrix environment.
• Strong digital fluency and willingness to leverage digital technologies, data, and new tools to improve ways of working.

Desirable Requirements

• Strong project management skills and experience managing timelines, priorities, and stakeholder expectations.
• A proactive, objective-driven personality with a can-do mindset, curiosity, and openness to change.
• Ability to solve complex analytical and project-related challenges in a creative, structured, and effective way.Experience acting as a key analytical expert in audits or inspections.
• Proficiency in German is beneficial.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: €66,918 to €117,800

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon join