Process CMC Principal Statistician - Vaccines
Sanofi

Job Title: Process CMC Principal Statistician - Vaccines

Location: Waltham, MA

About the Job

In the race for the future of health - The Sanofi mRNA Center of Excellence (CoE)

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.

That's why we're looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We're investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!

About the Opportunity

As an experienced mRNA Process CMC Principal Statistician, you will lead and coordinate the statistical support to the mRNA CoE scientists / SMEs (Subject Matter Experts)/engineers for process, formulation and analytics of mRNA Drug Substance (DS) and Drug Product (DP); as part of the Data and Computational Science team in the mRNA CoE. This team brings end to end data integration and advanced analytics (pre-clinical, biomarkers, process development, CMC, clinical) in the mRNA CoE. Deploying and exploiting digital solutions (AI/machine learning, data, analytics) to integrate the full data value chain, extracting actionable information for a move to a full data driven strategy and decision-making process, to increase probability of success and to accelerate mRNA vaccines and therapeutics development and launch.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilties:

• Represent the mRNA CoE Data and Computational Science team in platform and project technical teams as statistical subject matter expert and drive strategic CMC initiatives within the DS/DP and CMC data strategy
  
• Ensures to high reliability, quality, and optimization by providing an appropriate statistical support to process development, analytical and CMC teams in both GMP and non-GMP studies
  
• Bring statistical expertise and innovation around computational and statistical approaches towards mRNA process development and analytics for projects and cross-platform optimization (use of in silico methods - statistical modelling, simulation, machine learning - for improving bioprocess yields, biophysical stability, and safety profiles of mRNA vaccines and therapeutics)
  
• Bring statistical expertise and leadership in the design of experimental protocols, in the realization and interpretation of the results of statistical analyses and their presentation, automation and standardisation
  
• Design and execute the statistical analysis of complex or critical studies, which might be intended to Health Authorities with writing of statistical study rapports according to the established practices/standards and to participate to the answer to the questions from the Agencies on the registration dossiers and on various regulatory variations/commitments
  
• Lead training of scientists to statistical methods and to the use of validated " end-user " statistical applications
  
• Lead or contribute strategically in global initiatives of harmonization of the practices (within the mRNA CoE and within the partner organizations)
  
• Maintains a well-documented, reusable codebase, and traceable model history
  
• Maintains awareness of latest developments in relevant fields, evaluates and applies as warranted
  
• Generates IP and participates in the drafting of patent filings
  
• Lead preparation and publication of scientific papers and congress reports.
  
• Demonstrate good software engineering practices
  
• Proactively identify, assess, and internalize emerging technologies and methods
  

About You

• Earned PhD in Statistics or other related STEM field required
  
• Recognized leader with at least 5 years' experience in the field of non-clinical statistics applied to biopharmaceutical development and manufacturing is required
  
• Experience collaborating with process and analytical scientists and engineers on the development of biotherapeutics, ideally in the following domains:
  
  • Experimental designs in the context of the development and of the qualification/validation of processes following the QbD approach (selection of experimental design matrices, statistical analysis/modelling of results)
    
  • Statistical modelling & simulation of DS/DP processes
    
  • Statistical process control (univariate & multivariate)
    
  • Validations & transfers of analytical methods (protocols, statistical analysis)
    
  • Statistical analysis of DS and DP characterization and activity tests, stability studies, and comparability studies
    
  • Statistical analysis performed in a GxP environment
    
• Mastery of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulation (including Machine Learning) is helpful
  
• Confirmed expertise in process modelling, batch evolution model, and process monitoring
  
• Mastery of statistical and mathematical software (R, Python, JMP, Minitab...) is helpful
  
• Knowledge on CMC regulatory guidelines (ICH Quality, Pharmacopeias) and white papers (ISPE, PDA) and experienced in preparing and presenting proposals and regulatory files to internal and external audiences, including regulatory authorities is preferred
  
• Scientific rigor, organization and project leadership
  
• Good networking skills and fluent interactions with one or more scientific communities, with strong communication and teaching skills is needed
  
• Understanding of vaccine development processes is a plus, as well as familiarity with RNA processes and RNA-centric techniques/methods
  
• Fluent in English (French is a plus)
  

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
  

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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