Sanofi Group Scientist, Biologics Drug Product Development in Framingham, Massachusetts
This role is will be primarily responsible for developing injectable dosage forms (liquid, lyophilized or frozen drug product) for clinical and commercial use, including formulation development, drug product process development and scale-up, product characterization, technology transfer, and GMP manufacture support. Specifically:
Design and conduct studies to assess physicochemical stability of biologic drug candidates and lyophilized drug product, including solid state characterizations
Design and execute formulation development and optimization studies for biopharmaceutics
Develop plans for and assist in process development studies for routine manufacturing unit operations for injectable dosage forms (e.g. freeze-thaw, mixing, filtration, filling, lyophilization etc.)
Work closely and independently with counterparts from other functional areas to deliver on CMC milestones while adhering to broad project timelines
Lead and participate in technical team discussions
Supervise/mentor junior staff as required and provide technical leadership to the team
Generate, analyze, and present study data and results for team and senior management discussions; author development reports and documents for regulatory filing
Maintain a strong work ethic and good documentation practices including electronic laboratory notebook maintenance
Ph.D. in Biochemistry, Molecular Biology, Pharmaceutics, Pharmaceutical Chemistry, Bioengineering or a related discipline or a Master’s degree with a minimum of 4 years of relevant industry experience or a Bachelor’s degree with a minimum of 6 years of relevant industry experience
A thorough understanding of protein structure, chemistry and stability attributes to formulation and process development
Hands-on experience with bioanalytical instrumentation, such as SEC, DLS, NanoSight, SDS-PAGE, IEF/cIEF, spectroscopy and calorimetry
Experience in formulation development for liquid and lyophilized drug products
Experience handling and maintaining mammalian cell culture, including in the use for in vitro screening as well as ex vivo applications (e.g. patient derived)
Experience with biophysical characterization, thermodynamics and mechanistic understanding of protein degradation, protein-protein, and protein-excipient interactions.
Experience in Lyophilzation cycle development and scale up
Experience with solid state characterization of lyophilized solid dosage forms
Basic understanding of statistical data analysis and process modelling
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.
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