Analytical Expert Oral Late Phase Development
Posted on Mar 22, 2021 by Michael Bailey Associates - UK Contracts
Job title: Analytical Expert Oral Late Phase Development - Senior Scientist
The line function Analytical Research and Development (ARD) is within the Global Technical R&D department of Global Drug Development (GDD) and plays an essential role in the characterization, analysis and control strategy setting 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.
The client is looking for a highly motivated Analytical Expert in the field of small molecules essentially intended for oral administration focusing on late phase development, registration and launch preparation activities.
* Designing, planning, performing, interpreting and reporting results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
* Writing & reviewing analytical documents (eg 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, proposing creative solutions and communicating key issues to the appropriate management level and respective technical project team.
* Working according to appropriate SOPs, GMP, Quality Directives, Health and Safety internal Novartis guidelines as well as external regulatory requirements.
* Minimum: Master in analytical chemistry or equivalent. Desirable: Advanced degree in a scientific discipline (eg Ph.D. or equivalent in chemistry/pharmaceutical or analytical science).
* At least 2 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 highly dynamic environment.
* Advanced knowledge of laboratory and/or technical tools (eg HPLC, Dissolution rate, Quality management systems, statistical evaluation tools)
* Good knowledge of commonly used software and computer tools.
* Good presentation skills and scientific/technical writing skills.
* Fluent in English (oral and writing). German desired.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.