Description
Sanofi is seeking a motivated analytical research and development scientist to join the Analytics group located at 350 Water street, Cambridge, MA. The Analytics group combined with Synthesis Development, Biopharmacy and Early Formulation Development constitutes the Early Development organization in the US (EDUS) which provides the CMC expertise to advance projects from late-stage research through early clinical development up to Phase 2 clinical trials. As part of the Global CMC Development organization, EDUS is striving to become an industry leader in the development of transformative medicines.
Reporting to the Senior Director of Analytics, the scientist will contribute to or be responsible for the analytical method development, analyses, characterization of research and development compounds, process impurities and degradants. The scientist will also work closely with scientists at the Integrated Drug Discovery (IDD) to develop assays for compound screening and optimization. The scientist is also expected to develop assays and perform analysis of selected biomarkers to support drug development programs.
Key Responsibilities
- Collaborate with Formulation Development, Biopharmacy, Synthesis Development, Medicinal Chemistry, Process Chemistry and Process Engineering groups, as well as scientists from various therapeutic areas to support pre-development and early development activities.
- Develop methods and perform experiments for the identification and quantification of process impurities and degradants by LCMS.
- Develop and implement platform analytical methods to support process chemistry and process engineering and provide local analytical support as needed.
- Develop LCMS based assays to support compound screening and optimization.
- Develop methods and perform analysis of targeted biomarkers.
- Promote compliance on Health, Safety and Environment in the analytical laboratories.
Basic Qualifications
- PhD in Analytical Chemistry or related sciences within the pharmaceutical/biotech industry.
- Demonstrated experiences in supporting process chemistry and process development teams in impurity identification and impurity tree determination.
- Familiarity with the operation of HRAMS instruments and UHPLC systems.
- Broad knowledge of LC/MS/MS applications and other separation technologies complementary to LCMS.
- Ability to work in a cross-functional environment.
- Good communication skills.
Preferred Qualifications
- Knowledge of QbD concepts, specification setting, and cGMP, with experience in contributing to regulatory submission.
- In-depth understanding of separation principles of liquid chromatography and ion mobility.
- In-depth understanding of the principles of tandem mass spectrometry and state-of-the-art ion dissociation techniques.
- Demonstrated ability to solve complex problems with advanced LC/MS techniques.
- Prior experiences in the development of LCMS methods to support biochemical assays.
- Ability to handle multiple assignments.
