Scientist - Analytical Chemistry

• Planning, interpreting and reporting results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
• Performing raw data checks for externalized activities
• Writing & reviewing analytical documents (e.g Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and aligning the corresponding activities within a global project team.
• Managing interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary.
• Proactively identifying scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
• Working according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Novartis guidelines.

• PhD or minimum Master in analytical chemistry or equivalent
• At least 5 years' experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
• Profound expertise in analytical raw data documentation, documentation writing (Stability Report, Validation etc)
• Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
• Advanced knowledge of laboratory and/or technical tools (e.g. HPLC, LC-MS, Quality management systems, statistical evaluation tools ...)
• Good knowledge of commonly used software and computer tools.
• Good scientific/technical writing skills.
• Fluent in English (oral and writing),
• Experience is Inhaled dosage form is highly desirable (Must Have)

Michael Page