摘要
Location: Ivrea, Italy #Hybrid
Role Purpose:
Plan, perform and report scientific experiments with SME (subject matter expert) to support the project portfolio and/or advance the innovation technical platform of radiopharmaceutical parenteral dosage forms. Contribute to maintenance of laboratory instruments/infrastructure.
**Please note that this role will be based 100% in Ivrea
About the Role
Major Activities
- Plan together with FPL (formulation project leader) and perform formulation development, characterization studies and experiments.
- Ensure correct, comprehensible, structured, complete and legible documentation according to SOPs, HSE and AdAcAp / Novartis Guidelines.
- Meet quality, quantity and timelines in all assigned projects. Ensure all own activities are aligned with overall drug development process.
- Ensure correct and timely filling of logbooks and eLN experiments as per local procedures.
- Ensure strict adherence to HSE rules and guidelines. Strictly respect existing laboratory workflows (e.g. shipments and materials management).
- Plan together with AE (analytical expert) and execute analytical tests and analytical method development tests to support formulation and process development (e.g. HPLC chemical and radiochemical purity methods, content by UV, identity, pH, osmolality, visible particles)
- Participate to the transfer of analytical and/or manufacturing procedures.
- Ensure training is up-to-date and on time; no overdue training assignments without acceptable cause.
- Provide documentation of raw data and contribute to interpretation of the results.
- Keep record of chemicals, intermediates, excipients and solvents within own area of responsibility.
- Work actively to create lab procedures, reports and/or instructions and/or SOP’s.
- Contribute to the evaluation of new lab equipment and prepare CAR and USR if applicable.
- Ensure contribution to networks/workstreams/initiatives and ensure sharing of actions and learnings across the local or global teams as applicable.
Impact on the organization:
Support RLT drug development and drug manufacturing by delivering drug products procedures and processes
Ideal Background
Education:
Master’s degree in a scientific field with a minimum of 1-3 years of relevant experience within the pharmaceutical/biotech industry
Languages:
Good knowledge of English (oral and written). Fluent knowledge of site language
Experience / Professional requirements:
- Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
- Adequate scientific or technical knowledge in a specific area (e.g. synthetic, analytical, pharmaceutical).
- Good knowledge of quality control and production of pharmaceuticals
- Adequate knowledge in scientific/technical areas of collaboration.
- Good knowledge of laboratory and/or technical tools.
- Adequate knowledge of software and computer tools.
- Basic presentation skills and scientific/technical writing skills
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? http://www.novartis.com/about/strategy/people-and-culture
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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.