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Sanofi Group Professional Development Associate , Data Science - Vaccine in Meriden, Connecticut

The Analytical and Formulation Development group supports the development, manufacture, and improvement of Flublok influenza vaccine, development of COVID19 vaccine and the development of other vaccine candidates, including pandemic influenza vaccines. Development work includes the characterization of target proteins due to annual strain changes, process improvements, and or process changes. In addition, the team is responsible for the development of new and improved assays and for the identification of formulation conditions to improve stability and increase shelf-life. The group supports vaccine manufacture through batch monitoring and leads investigations into process related deviations. The team is also responsible for the batch monitoring of the COVID 19 DS batches produced at various CMOs to demonstrate the process consistency and the robustness of the process.

Position overview/Key responsibilities:

This position provides a unique opportunity to the Development Associate for participation in Statistical Process Control (SPC) and data analysis of the COVID 19 Drug substance batches produced across Sanofi Sites and also at CMOs. The candidate also participate in the biophysical characterization of vaccines including viral vaccines, recombinant protein vaccines, and virus like particles. As a member of the Analytical Formulations team, the candidate will work closely with her/his manager to develop and optimize analytical assays to characterize vaccine targets, and analyze and trend data for vaccine life cycle management. Candidate will accomplish these tasks in a laboratory setting and through collaborations both internal and external.

Responsibilities include:

  • Utilize the established process monitoring procedures, systems and tools, and Statistical process control system and tools for the process monitoring of the COVID DS batches produced across sites and by CMO. Coordinate data collection, check the data quality, and perform data analysis under the guidance of the lead data scientist. Publish the data in the form of a Monthly Robustness Report.

  • Participate on cross functional teams to support development work by providing:

  • Design of experiments

  • Statistical analysis

  • Root cause investigation

  • Data modeling

  • Design and execute studies to evaluate changes to manufacturing processes, equipment and/or site, and to evaluate the stability of novel protein candidates.

  • Provide and write status updates, status reports, assessments, development reports, procedures,

  • Present ideas, concepts, and findings internally and externally and represent the company at national and international scientific conferences.

Basic Qualifications:

  • BS/MS degree required in one of the following disciplines: Applied Mathematics, Statistics, Biochemistry, Biophysical Chemistry, Biology, Pharmacy or Biomedical Engineering

  • Certified in SAS, Statistics/Data analytics

  • Knowledge of Data Analytics, Bioprocess Upstream/Downstream

  • 1-3 years of experience in SPC/Data analytics in Biotech Industry

  • Tools: JMP Script / Coding experience a MUST; MS-Excel

Preferred Qualifications:

  • Digital and Innovation mindset

  • Six Sigma certification

  • Experience in biophysical and biochemical characterization of proteins and a familiarity with state of the art biophysical and biochemical assays such as DSC, DLS, DSF, Bi-layer Interferometry, and UPLC is a plus.

  • Familiarity with cGMPs and/or vaccine manufacturing is a plus.

  • Excellent verbal and written communication skills.

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.

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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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