Senior Expert Science & Technology (Analytical Operations)

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

Zusammenfassung

Novartis in Schaftenau, Austria seeks a Senior Expert in Science & Technology to lead GMP‑analytical activities within Analytical Operations for biologics development. You will coordinate release testing, stability studies, validation, and method transfer, ensuring timely, compliant support for clinical projects.

Responsibilities include authoring submission‑ready documentation, data interpretation, and cross‑functional collaboration, with a future‑macing digital approach across teams.

Qualifikationen

• Master's degree or PhD with industry experience in analytical development.
• Proven experience with analytical methods in biotech/pharma settings.
• Strong GMP knowledge and quality expectations.
• Experience with HPLC/CE and related analytical technologies.
• Excellent scientific writing and documentation skills.
• Fluent English; strong cross-functional communication.

Aufgaben

• Provide GMP‑related analytical leadership for global project sub‑teams.
• Manage release, stability studies, validation, transfer of analytical methods.
• Coordinate analytical activities across multiple priorities and resources.
• Author/review protocols, reports, and GMP documentation.
• Interpret analytical data and draw scientifically sound conclusions.
• Address deviations and quality events within projects.
• Support troubleshooting of methods and processes with teams.
• Contribute to budget planning and resource forecasting.
• Drive knowledge sharing and continuous process improvements.
• Ensure compliance with GMP, HSE, and Novartis standards.

Kenntnisse

GMP knowledge

Analytical methods

HPLC

CE

Scientific writing

Cross-functional collaboration

Ausbildung

Master's degree in biotechnology or related

PhD in a relevant field (optional)

Tools

LIMS

Chromatography data systems

Jobbeschreibung

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 analytic sub‑teams and ensuring timely, compliant, and scientifically sound support for clinical development projects.

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 analytic 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.

About The Role

Key Responsibilities

• Provide scientific guidance and lead GMP‑related analytical activities within global project analytic 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 joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance‑based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Adjustments for Applicants with Disabilities

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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