Sanofi Group Scientist I in Framingham, Massachusetts
Location : Framingham, MA
The Scientist I position is part of the Upstream function in Manufacturing Science & Technology (MSAT)-Drug Substance (DS) and is based at the biologics hub in Framingham, MA. The MSAT-DS function within Specialty Care Operations (SCO) assures robustness and economics of cell-culture based manufacturing processes in support of life cycle management (LCM) of biological proteins expressed from mammalian systems by:
Driving next generation process development & supporting key strategic initiatives
Leading technology transfer, scale-up development & adaptation, process automation, process control strategy, process validation, and comparability for SCO product introduction at Sanofi and external industrial sites
Providing technical assistance for commercial manufacturing at Sanofi & external sites including change assessment, process monitoring, troubleshooting, and continuous process improvement for drug substance.
Position Overview / Key Responsibilities:
Scientist I will apply scientific and engineering principles and utilize cell culture, bioreactor, and separation technologies to improve current commercial and develop next-generation processes of monoclonal antibodies, enzymes, fusion proteins, and other recombinant proteins, with responsibilities spanning process development & characterization, as well as support of technology transfer & advanced manufacturing investigations.
This individual will work in a team environment, collaborating with various colleagues in theorganization to solve a wide range of complex problems in creative and practical ways.
Analyze process development and commercial manufacturing data in support of the MSAT mission
Design and conduct value-added experiments; interpret results; build process understanding and recommend changes
Lead a small project team for LCM Upstream process improvements and implementation in manufacturing
Contribute to/lead technology transfer efforts of small project team between groups/organizations
Contribute to technical investigations of complex deviations in manufacturing
Contribute to establishment of best practices and technical ways of working within development and manufacturing teams
Provide technical training and know-how to manufacturing teams and less experienced staff
Collaborate with other scientists/engineers across the biologics manufacturing network within Sanofi and with partnership organizations
Responsible for internal documentation and preparation of reports required for regulatory documents
Support regulatory filings and interaction with authorities as subject matter experts
Present data and results within department and project teams
Bachelor’s degree required, preferably in chemical engineering, biology, biochemistry or the like AND 6+ year's Bio/Pharma industry experience, OR
Master's degree required, preferably in chemical engineering, biology, biochemistry or the like AND 4+ year's Bio/Pharma industry experience
Hands-on experience at laboratory, pilot, or manufacturing scale for biologics products
Strong experience in one or more areas of upstream process development ; process transfer, process scale-up/scale-down, validation, and continuous process verification as applied to mammalian-expressed proteins
Experience with automation software (such as Delta V, PI, or other) for development and manufacturing, data monitoring and analysis
Experience with statistical analysis software
Solid understanding of cGMP commercial biologic manufacturing operations
PhD with 0-2 year's industry experience
Familiarity with root cause analysis and/or risk assessment
Experience of working in a team environment with other technical staff
Excellent scientific background and presentations skills
Highly motivated individual with the ability to work independently as well as on cross-functional and cross-site teams
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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