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 and analysis 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 a highly motivated Analytical Expert in the field of small molecules and oligonucleotides.
Your main responsibilities:
- 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 guidelines.
- PhD or minimum Master in analytical chemistry or equivalent
- At least 4 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), German a plus
For more information, please contact Fandi Hatib on +44 1727 817 600 or email firstname.lastname@example.org
- Agency: Achieva Group Limited
- Reference: FH-33-2
Website: Achieva Group Limited
- Posted: 6th June 2022
- Expires: 4th July 2022