Sanofi Group Biopharmaceutics Scientist in Cambridge, Massachusetts
Sanofi is seeking an experienced Biopharmaceutics scientist with self-motivation and enthusiasm to join the Early Development group located in Waltham/Cambridge, MA. The Early Development department provides the CMC expertise to advance projects from late stage research through early clinical development. As part of the Global CMC Development organization, Early Development is striving to become an industry leader in the development of transformative medicines with scientific excellence and agility.
Reporting to the Head of Biopharmaceutics, the Scientist will lead the biopharmaceutics activities in multidisciplinary project teams including:
Develop and advance concepts of translational biopharmaceutics with a focus to improve predictive capabilities by linking in vitro drug product performance attributes to in vivo performance attributes.
Assist in combining leading edge in vitro and in silico capabilities with drug product design.
Design and perform in vitro experiments to evaluate drug products using principles of quality by design.
Work in close collaboration with various groups to address the biopharmaceutics needs of oral, parenteral, transdermal, and other delivery routes.
Basic Qualifications :
Ph.D. in Physical Chemistry, Pharmaceutics, Biochemistry, or related discipline with a minimum of one year of relevant industry or academic experience or a master’s degree with a minimum of 4 years of relevant industry or academic experience in industry.
Experience with formulation and dissolution experiments.
Experience in generating and interpreting experimental data; understanding of formulation development, pre-formulation studies.
Strong organizational and communication skills.
Ability to prioritize and manage multiple projects and activities while meeting tight deadlines.
Proactive in problem-solving and be able to independently manage timelines and priorities.
Experience with modeling and PK software, i.e., Matlab, R, Python, WinNonlin, NONMEM, Gastroplus, Simcyp or similar programs.
Demonstrated abilities to work in cross-disciplinary teams and ability to partner with cross disciplinary subject matter experts in Pharmaceutical Sciences, Pharmacokinetics & Drug Metabolism and Clinical Pharmacology departments.
Demonstrated experience in the development of enabling formulations such as spray dried amorphous dispersions, lipidic formulations, nano-crystal formulations.
Experience in writing documents for regulatory submissions and responding to health authority questions.
Experience with outsourcing and overseeing work done by CRO/CMOs.
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.
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.