Analytical Research and Development (ARD) sits within Development / Technical R&D and plays an essential role in the characterization, analysis and control strategy definition of small molecules and synthetic large molecules Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to commercial production.
We are looking for highly motivated Analytical Experts in the field of small molecules for oral administration focusing on early development including pre-clinical activities and/or late phase development, registration and launch preparation activities.
Your responsibilities will include, but are not limited to:
- Designing, planning, supporting the execution as well as interpreting and reporting results of scientific experiments for the development and timely supply of drug substances (DS) and drug products (DP) intended for pre-clinical and clinical development as well as potential commercialization.
- Interpreting analytical data as well as authoring & reviewing supportive analytical documents (e.g analytical procedures, specifications, product characterization reports, validation protocols/reports, stability protocols/reports as well as batch records compilation and line function material disposition 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 appropriate management level and respective technical project team.
- Collaborate with the Analytical Project Leaders, analytical project team members, wider analytical community as well as partnering technical functions applying state of the art analytical science, technologies and processes.
- Working according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Novartis guidelines.
In order to successfully fulfill this role the analytical expert should bring the following qualifications:
- Minimum: Bachelor in analytical chemistry or equivalent with significant experience in analytical development of drugs.
Desirable: Advanced degree in a relevant life science scientific area (e.g. Master, Ph.D. or equivalent in chemistry / pharmaceutical or analytical science). - Preferably 5 years’ experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
- Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a global and highly dynamic environment.
- Advanced knowledge of analytical techniques and associated processes (e.g. HPLC and corresponding Chromatographic Data System, Dissolution rate, GxP Quality Management Systems, statistical evaluation tools ...). Additionally, considering that the activities will primarily focus on the development of oral dosage forms, knowledge in dissolution rate testing as well as drug substance solid state properties such as particle size distribution, solubility and polymorphism is essential.
- Good presentation skills and scientific/technical writing skills and associated IT Tools.
- Fluent in English (oral and writing), German is advantageous.
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.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to E-Mail schreiben and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
