Sanofi Group Principal Research Associate- Framingham/MA in Framingham, Massachusetts
The Principal Research Associate (PRA) will be responsible for formulation and process development for protein and monoclonal antibody therapeutics for liquid and lyophilized dosages. Key expectations and training will include good understanding of protein stability, protein degradation mechanisms, formulation and process development, process scale up and transfer. Hands-on experience in container/closure selection, excipient screening, formulation optimization and robustness, stability study, forced degradation, and drug product characterizations. Skills in common biochemical and biophysical techniques for biologic sample characterization. Working knowledge in overall biopharmaceutic development process and regulatory compliance. Good written and verbal communication skills for effectively participating in team discussions and for authoring study reports and regulatory filing documents.
- Bachelors degree in Biochemistry, Molecular Biology, Pharmaceutics, Pharmaceutical Chemistry, Bio-engineering or a related discipline, and 4+ years of experience; or Master’s degree in the similar fields and 2+ years experience
A solid understanding of protein structure, chemistry and stability attributes.
Expertise in protein formulation development from excipient selection, formulation screening and optimization, and DoE based robustness.
Experience in drug product process development, process scale up, process control strategy, and technology transfer.
Hands-on experience with common analytic technologies, such as SEC, IEF/cIEF, spectroscopy, DLS, viscometer, calorimetry, and subvisible particle analysis.
Working knowledge in regulatory compliance, global product development strategies, and GMP manufacturing.
Experience with biophysical characterization on bio-formulation and drug product, good understanding in protein degradation and interactions.
Design and execute development studies independently with minimal supervision, and ability to work effectively in a team environment.
Good written and verbal communication skills for data presentation and for study reports/regulatory documents writing.
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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