Job Description

Position Overview:

As a scientific research and development team member, the Sr Scientist is responsible for the formulation development to enable GLP toxicology studies and IND filings. The Sr Scientist will assess lead candidates developability, develop fit for purpose formulation, be responsible for stability studies and biochemical and biophysical characterization to support CMC development and manufacturing. He/She will coordinate with stakeholders and provide feedback to project teams. The Sr Scientist will also be responsible for managing and developing junior scientists while supporting R&D activities.

Key Responsibilities:

Design and implement pre-formulation screens to assess developability and rank order candidates.
Develop fit-for-purpose formulation supporting GLP and IND-enabling activities.
Practice biophysical tests with an extensive understanding of principles, e.g. DSC, DSF, CD, ITC, DLS, SEC-MALS, etc.
Perform chromatographic methods, e.g. SE-HPLC, RP-HPLC and IEX; assay optimization and troublehshooting for stability studies.
Develop stability protocols for GMP and non GMP studies. Participate in quality investigations as needed.
Miniaturize sample consumption in assays used for screening lead candidates.
Working knowledge of protein characterization by CE-SDS, LC-MS, and cIEF is preferred.
Work seamlessly with members of the CMC and research teams locally at Synthorx and globally with Sanofi, to select candidates and establish the critical path for candidate assessment.
Work collaboratively with CROs and CMOs for technology transfer and manufacturing support as needed.
Write study reports summarizing the development activities is required.
Ensure instruments are in proper working condition and work with vendors to fix issues that arise.
Basic Qualifications:

PhD and 7 years relative industry experience.
Proficiency in HPLC, DSC/DSF, DLS, CE-SDS, etc.
Proficient in principles and practice of biophysical methods for the characterization of biologics.
Experience in biologics pre-formulation screens, and formulation development.
Prioritize project needs in alignment with strategic company goals.
Draft study reports, peer reviewed scientific publications, and data for patent applications.
Proficiency in basic computer data analysis and presentation applications: e.g. Microsoft Word, Excel.
Independent design and execution of experiments, data analysis, and interpretation of results.
Effective interpersonal skills, including written and oral communication skills.
Excellent time management and organizational skills, ability to multi-task, and excel in dynamic work environment.
Experience in ICH, USP, EP and FDA guidelines, and GMP principles.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.