Summary
Leitung eines Teams für die Entwicklung von pharmazeutischen/biologischen/Zell-Gen-Therapien, das in einer kleinen Produktionsanlage arbeitet. Setzen Sie die funktionale Strategie um und treiben Sie die operative Exzellenz im Einklang mit der Vision und Strategie von TRD voran. Sicherstellung der vollständigen Portfoliounterstützung im Einklang mit den Plänen von GDD, Sandoz, NTO und NIBR.~SANDOZ:
~Associate Scientist: Entwerfen, Planen, Durchführen, Interpretieren und Berichten von Ergebnissen wissenschaftlicher Experimente für die Entwicklung und rechtzeitige Verabreichung von Arzneimitteln (DP), Prozessen und Verfahren innerhalb eines multifunktionalen Projektteams, das von einem Projektleiter koordiniert wird. Verwalten Sie technische Labor-/Anlagenaktivitäten.~Wissenschaftler:
~Design, Planung, Durchführung, Interpretation und Berichterstattung über die Ergebnisse wissenschaftlicher Experimente für die Entwicklung und rechtzeitige Verabreichung von Arzneimitteln (DP), Prozessen und Verfahren. Leitung und Verwaltung aller Projekt-/lokalen Netzwerkaktivitäten, Unterstützung/Coaching von Teammitgliedern, Teilnahme an Unterteams und Beitrag zu allgemeinen SZ-Strategien und -Zielen~Senior Scientist: Entwerfen, Planen, Durchführen~Dokumentieren und Interpretieren von wissenschaftlichen/Entwicklungsexperimenten und GMP-Tests oder Pilotanlagenprozessen für die Vorbereitung und rechtzeitige Lieferung von generischen Produkten, Prozessen oder Verfahren; Wartung und Qualifizierung von Geräten/Infrastruktur und Verwaltung der betrieblichen Aspekte im Labor oder in der Anlage wie zugewiesen.
About the Role
Your key responsibilities
As Mass Spec Expert you are responsible for operating our mass spectrometry instruments and conducting analysis of Biologics samples. You will be part of the Process Analytical Sciences at our TRD Biologics site in Austria.
Your responsibilities include, but are not limited to:
Method Optimization using Quality-by-Design (QbD) Principles: Applying QbD principles, drive and execute the liquid chromatography-mass spectrometry (LC-MS) method development and optimization of assigned pipeline projects for all relevant sample matrices (Drug Substance, Drug Product, Intermediates). Design experiments, perform risk assessments, and utilize statistical tools to develop robust and reliable analytical methods. Data Analysis and Interpretation: Analyzing mass spectrometry data, interpreting the results, and generating detailed reports summarizing the findings. Further build out the use of automated analysis like MAM (Multi Attribute Method) Data-Driven Approaches: Utilize data analytics, machine learning, and artificial intelligence to analyze large datasets and develop data-driven approaches for method development. Identify critical quality attributes, process parameters and correlations to optimize method performance. Regulatory Compliance: Ensure compliance with regulatory requirements and support filings applying principles described in recent guidelines (e.g. ICH Q2(R2) and Q14). Stay updated on evolving regulatory expectations e.g. related to validation strategies. Documentation and Presentation: Maintaining detailed records of experiments, procedures, and results, and effectively presenting findings through written reports, presentations, and scientific publications. Collaboration: Working closely with other scientific and technical staff to design experiments, interpret results, and provide expertise in mass spectrometry techniques.
What you’ll bring to the role
- Strong understanding of mass spectrometry principles
- Hands-on experience with various mass spectrometry techniques
- Excellent analytical and problem-solving skills, and a meticulous approach to laboratory work
- Good communication skills to collaborate with colleagues and present findings effectively
- Expertise in applying QbD principles
- Expertise in automation and data & digital
- Sound technical and scientific knowledge of pharmaceutical development, analytical sciences, or equivalent
- Significant experience in biotechnological CMC development
- Ability to work in a matrix environment
- Influencing without authority
Desirable requirements
• University degree in life sciences with practical experience in Physico Chemical Analysis (e.g. Biotechnology, Chemistry, Pharmacy)
• Minimum of 2 years of proven experience in the pharmaceutical industry
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €54,735.38/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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 [email protected] 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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Unterstützungen für BewerberInnen mit Behinderungen
Wenn Sie aufgrund einer Erkrankung, einer körperlichen Behinderung oder eines neurodiversen Zustandes eine Unterstützung bei terschiedlichen Teilen des Rekrutierungsprozesses benötigen, wenden Sie sich bitte an [email protected] und teile n Sie uns die Art Ihrer Anfrage sowie Ihre Kontaktinformationen mit. Unsere Unterstützung umfasst die Beratung zu geeigneten Positionen sowie die Begleitung bei allen Phasen des Bewerbungsprozesses. Das österreichische Gesetz sieht die Möglichkeit vor, die örtliche Behindertenvertrauensperson (BVP) in das Bewerbungsverfahren einzubeziehen. Wenn Sie dies wünschen, teilen Sie uns dies bitte vorab als Vermerk in Ihrem Lebenslauf mit.
