摘要
Design and plan scientific experiments as well as report and interpret results/outcome in line with the overall TRD RLT 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
Key responsibilities:
- Execute and report RLT DS and/or DP analytical activities through advanced analytical science and technologies following agreed timelines and quality standards.
- Coordinate analytical aspects of project development for RLT and align the analytical strategy with APL and DPPL/FPL.
- Develop and disseminate best practices with strong scientific expertise within the analytical project team.
- Create analytical documents supporting the analytical and global project strategies based on project phase, ensuring availability of all relevant GMP and source documents.
- Carry out and qualify analytical methods in line with ICH guidelines and specific references to quality control of radiopharmaceuticals.
- Assist in setting specifications suitable for the current development stage, aligning with the TRD RLT project team.
- Aid in the transfer of analytical procedures to manufacturing sites and radiopharmacies.
- Adhere to relevant SOP’s, GLP, GMP, OQM, HSE, ISEC and AdAcAp/Novartis guidelines and cultivate a strong team spirit.
Essential requirements:
- Hold a Master’s degree in chemistry, pharmaceutical technology, or a related degree with a minimum of 2 years' industry experience in analytical chemistry and/or radiochemistry development and/or quality control.
- Proficient in English (both oral and written), with the preferred knowledge of the site language.
- Understands GMP principles, current and anticipated regulatory and quality expectations specifically within the radiopharmaceutical industry.
- Experienced in writing CMC documents for regulatory submissions and responding to health authority inquiries.
- Mindful of safety measures when handling chemicals, potentially hazardous materials, and equipment.
- Detail-oriented and committed to quality.
- Possesses good communication skills, including presentation and scientific/technical writing.
- Demonstrates excellent problem-solving and decision-making skills.
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
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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.
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Innovative Medicines
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl
Research & Development
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.