Senior Expert Science & Technology (Extractables and Leachables)

Novartis; Schweiz; Hybrid; EUR 66.000 - 118.000; Vollzeit

Benefits dieser Stelle

Hybrid work options

Competitive base salary

Performance-based incentives

Comprehensive benefits

Zusammenfassung

Novartis in Schaftenau, Austria, seeks a Senior Expert Science & Technology (Extractables and Leachables) to lead complex strategies across drug development, combining analytical science with regulatory innovation.

You will collaborate with global teams, design and oversee studies, interpret data, and author technical and regulatory documentation to support safe, effective medicines.

Hybrid work is available, with a competitive base salary and benefits.

Qualifikationen

• Advanced degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Strong expertise in Extractables and Leachables assessment within a regulated industry environment.
• Hands-on experience with chromatography and mass spectrometry techniques.
• Excellent scientific writing and ability to prepare regulatory documentation.

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 and regulatory submission content.
• Drive cross-functional collaboration to solve scientific and operational challenges.

Kenntnisse

Extractables & Leachables

Chromatography

Mass spectrometry

Scientific writing

Cross-functional collaboration

Ausbildung

Advanced degree in Pharmacy, Chemistry, Life Sciences, or related

Tools

LC-MS instruments

Chromatography systems

Jobbeschreibung

Salary Range

€65,606.00 - €117,800.00

Job Description Summary

#LI-Hybrid

Location: Schaftenau, Austria

Relocation Support: This role is based in Schaftenau, Austria. Novartis is unable to offer relocation support: please only apply if accessible.

Job Description

What if your expertise could help shape the future of medicines and ensure patient safety worldwide? As Senior Expert Science & Technology (Extractables and Leachables) (m/f/d), you will play a pivotal role in advancing innovative therapies by leading complex Extractables and Leachables strategies across the drug development lifecycle. Working at the intersection of analytical science, materials science and regulatory innovation, you will collaborate with global multidisciplinary teams, influence scientific decision-making, and drive solutions that support the delivery of high-quality medicines to patients around the world. This is an exciting opportunity to apply deep technical expertise while helping to redefine how we approach evolving scientific and regulatory challenges.

Key Responsibilities

• 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.

Essential Requirements

• Advanced degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.


• Strong expertise in Extractables and Leachables assessment within a regulated industry environment.


• Hands-on experience with advanced chromatographic and mass spectrometry analytical techniques.


• Proven ability to lead complex scientific projects and manage multiple priorities effectively.


• Excellent scientific writing skills with experience creating technical and regulatory documentation.


• Strong communication and collaboration skills with the ability to influence across multidisciplinary teams.

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: € 65,606 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.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and Accommodation

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.

Skills Desired

• Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.