Non-Clinical Process CMC Principal Statistician - Vaccine
Non-Clinical Process CMC Principal Statistician - Vaccine
Waltham, Massachusetts, Marcy-l'Étoile, France
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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 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.
About growing with us for winning with us
In this role you will :
Represent the mRNA CoE Data and Computational Science team in platform and project technical teams as statistical subject matter expert and contribute to the DS/DP and CMC data strategy
Contributes 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,
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 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
Competencies / Requirements for position
PhD in Statistics or Chemometrics
Recognized leader (> 5 years’ experience) in the field of non-clinical statistics applied to biopharmaceutical development and manufacturing
Experience collaborating with process and analytical scientists and engineers on the development of biotherapeutics, 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 (according to pharmacopeial requirements
Stability studies, 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 (incl. Machine Learning)
Confirmed expertise in process modelling, batch evolution model, process monitoring
Mastery of statistical and mathematical software (R, Python, JMP, Minitab...)
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
Good communication and teaching skills
Scientific rigor, organization and project leadership
Good networking skills and fluent interactions with one or more scientific communities
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)
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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