Περίληψη
Role Purpose:
Design, plan and perform Mass Spectrometry experiments as well as report and interpret results/outcome in line with the overall TRD RLT (Radioligand Therapy) project strategy for RLT Drug Substance(s) and Drug Product(s) in development. Ensure project knowledge generation and preparation/timely delivery of supplies with high quality and state of the art standards. Contribute to the analytical project strategy definition; drive scientific and operational excellence and thereby contribute to overall TRD RLT strategy and goals.
About the Role
Major Activities
- As Mass Spec Expert you are responsible for operating our mass spectrometry instruments and conducting analysis of Radioligands samples and training Formulation/Analytical Scientists on Mass Spectrometry topic. You will be part of the RLT Analytical Team at our TRD RLT site in Italy
- Drive, Lead and execute the Liquid Chromatography-Mass Spectrometry (LC-MS) method development and optimization of assigned Radioligands pipeline projects for all relevant sample matrices (Drug Substance, Drug Product). 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
- Regulatory Compliance: Ensure compliance with regulatory requirements and support filings applying principles described in recent guidelines. 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
- Follow the appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and Novartis guidelines
- Exhibit strong team spirit and promote knowledge exchange
Ideal Background
Education:
- Minimum: Master’s degree (ideally PhD) in Analytical Chemistry, Chemistry, Pharmaceutical Technology, or equivalent scientific degree with minimum 2 years of successful industry experience and/or proven experience with strong hands-on in the field of Mass Spectrometry characterization and method development.
Languages:
- Fluent knowledge of English (oral and written). Desirable knowledge of site language (Italian).
Experience / Professional requirements:
- Experience with small molecules characterization will be an advantage and highly appreciated
- Experience with Liquid Chromatography method development
- Experience with different Mass Spectrometry data processing software will be an advantage (e.g. Chromeleon, Freestyle, XCalibur, Genedata, Compound Discoverer)
- Awareness for safe handling of chemicals, potentially dangerous materials, and equipment
- Excellent analytical and problem-solving skills, and a meticulous approach to laboratory work
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.
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
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