Summary
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
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 disabilities.austria@novartis.com 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
