Analytical Expert
Novartis
Summary
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
You will 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn 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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.