Role Summary
Location: Cambridge, MA. Chromatography Principal Scientist role within Sanofi's analytical group, part of the Global CMC Development synthetic platform, focusing on small molecules. The primary responsibility is to provide analytical support to chemistry teams and to develop analytical methods using HPLC, UHPLC, GC, and potentiometry.
Responsibilities
- Develop specific and robust analytical methods using equipment including HPLC, UHPLC, GC, and be responsible for validating the methods when necessary
- Analyze synthetic molecules mainly by HPLC/UHPLC, GC, potentiometry, and TLC.
- Perform quantification of impurities
- Perform mass balance studies
- Design and implement analytical strategies for synthesis intermediates and raw materials
- Develop effective collaborations with others within project teams and between analytical groups
- Generate technical reports independently
- Share knowledge and experience of analytical method development for synthetic molecules
- Introduce innovative analytical approaches to facilitate optimal decision-making.
- May serve as a project lead
Qualifications
- Required: A Masterβs degree or equivalent in Analytical Chemistry or related field with a minimum of 8 years, or a PhD with minimum of 5 years of experience in the pharmaceutical/biotech industry. A PhD in Analytical Chemistry is preferred.
- Required: Expertise in the operation of LC and GC
- Required: Familiarity with the operation of potentiometry titrator, and TLC from multiple manufacturers
- Required: Extensive experience in method development using HPLC/UPLC and GC
- Required: Experience in analytical method validation
- Required: Record of adhering to and promoting lab safety practices
- Required: Good communications skills
- Preferred: In-depth understanding of the separation principles of LC, GC and method development software.
- Preferred: Deep expertise in chromatography method development and trouble shoots
- Preferred: Knowledge of QbD concepts, specification setting, and cGMP, with experience in contributing to regulatory submission
- Preferred: Communicates effectively in individual and group settings and collaborate effectively in a multi-disciplinary team setting
- Preferred: Demonstrated project management skills
- Preferred: Consistent record of collaboration with scientists and other stakeholders at external enterprises
- Preferred: Advanced scientific network in the industry and academia
- Preferred: Record of patents and publications