About the job
Position Overview:

Sanofi is seeking an experienced formulation scientist to join the Early Formulation Development group located in Waltham, MA. The Formulation Development combined with Synthesis Development and Analytics constitutes the Early Development US department which provides the CMC expertise to advance projects from late stage research through early clinical development. As part of the Global CMC Development organization, this department is striving to become an industry leader in the development of transformative medicines with scientific excellence and agility.

Key Responsibilities:

Develop, prepare, and characterize formulations suitable for use in drug discovery pharmacology studies, PK studies, and initial toxicology studies as follows:

• Carry out and interpret preformulation studies of potentially new drug candidates.
• Serve as formulation subject matter expert in project teams to provide strategic and experimental input to team in screening new chemical entities, lead optimization, and candidate selection
• Perform physicochemical and biopharmaceutical properties evaluation and drugability assessment for development candidate selection.
• Propose clinical formulation strategies, develop, and study prototype formulation for use in clinical studies.
• Work with appropriate internal and external partners (CROs) to identify, prioritize, and address critical drug product needs.
• Collaborate with bio pharmacy and other functions.
• Provide oversight to CROs and CMOs working on Sanofi projects
• Provide expertise to CMC efforts in late-stage research and early development

Basic Qualifications:

• Ph.D. in Pharmaceutics or related sciences with a minimum of 4 years of relevant experience within the pharmaceutical/biotech industry or a Master’s degree with a minimum of 8 years experience.
  
• Excellent laboratory skills and the desire to conduct lab work
• Demonstrated success in pre-formulation and developing early formulations for pre-clinical evaluations such as in vivo exposure, efficacy, and pharmacokinetic studies with an emphasis in oral/solid dosage forms
  
• Technical expertise and thorough understanding of drug product production technologies
  
• Proficient with state-of-the-art processing techniques for oral/solid dosage forms
  
• Demonstrated experience in the development of enabling formulations such as spray-dried amorphous dispersions, lipidic formulations, nano-crystal formulations
  
• Demonstrated expertise in biopharmaceutical analysis
  
• Experience with outsourcing and overseeing work done by CRO/CMOs
  
• Experience working with cross-functional teams
  
• Excellent communication skills
  
• Track record of scientific publications

Preferred Qualifications:

• Experience with software used in biopharma analysis such as GastroPlus and gPROMS
• Experience in providing directions to clinical pharmacies enabling on-site formulation
• Experience in the development of pivotal and commercial formulations
• Familiarity with late stage and commercial drug product manufacturing technologies
• Experience in writing documents for regulatory submissions and responding to health authority questions

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.

PDN

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.