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Sanofi Group mRNA Process Development - Scientific Data Transformation Lead in Waltham, Massachusetts

ABOUT THE CoE

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 500 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research platform with R&D, digital, and CMC teams.

Watch our Jobinar’s replay ( https://sanofi12.jobinar.com/ ) to discover more about the ongoing work at our Center of Excellence.

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 job

Our mRNA Data Continuum Ambition

With its long-standing expertise in developing and commercializing vaccines and other innovative medicines on a global scale, Sanofi has created a Center of Excellence (CoE) to accelerate innovation in the mRNA space.

At Sanofi, we believe that Data Analytics and Artificial intelligence (AI) can transform how we discover, develop, and deliver therapies. To achieve this vision, we need to establish a common data continuum ecosystem across diverse teams, including Research & Biomarkers (R&B), Process Development & Industrialization (PD&I), Analytical Sciences (AnSci), Clinical, Manufacturing, and various internal/external sites. To achieve this vision, mRNA CoE is looking for several scientific data transformation leaders embedded in its lab-based departments.

The mission of CMC PD&I department in mRNA CoE is to design, scale up and industrialize end-to-end manufacturing processs including pDNA, mRNA, LNP and Drug Product to support R&D pipeline from Phase 1 to licensure. CMC PD&I has laboratory and pilot scale capabilities in France and US where more than 100 scientists, engineers, and technicians are generating, and capturing a large amount of data. Embedded within CMC PD&I department, you will work closely with PD&I scientists, empowering them to transform their process development data practices from custom and isolated tools to a harmonized, interconnected data ecosystem to enable a full data-driven strategy to unlock mRNA promises.

In this role, you will:

Guide the transition : Analyze current data practices, identify areas for improvement, and develop and execute a roadmap for creating a unified data continuum.

Lead by example : Foster a culture of collaboration and data ownership among scientists and engineers.

Break down silos : Design and implement data pipelines to seamlessly connect diverse data sources.

Champion data hygiene : Drive the adoption of best practices for data quality and integrity.

Enable data access: Streamline data access and retrieval processes for all stakeholders.

Quantify impact : Develop metrics and track the positive impact of data transformation initiatives.

Build bridges : Collaborate effectively with groups in CMC PD&I and with counterparts in AnSci, R&B, and Data and Computational Science (DCS) departments.

Main responsibilities:

The scope of data process for this transversal role includes development data for pDNA cell bank and process, mRNA Drug Substance process, Lipid Nanoparticles formulation and process and Drug Product container closures and process. The lab studies support all stage of CMC development includes IND enabling, Ph1, Ph2, Ph3, Process Validation and regulatory dossier for several vaccines and non-viral gene therapy products.

Technical Analyst: CMC PD&I Data Processes Standardization

  • Work hands-on with 50+ scientists & technicians in specific sites to review and analyze current laboratory operations and data practices and guide them towards a new, impactful way of working.

  • Lead the alignment of scientific and data practices across different teams and sites within PD&I, ensuring a harmonized approach towards data management and utilization.

  • Collaborate with counterparts in AnSci and R&B departments to drive data process harmonization, and implement standardization initiatives to enhance data quality and accessibility.

  • Select and implement suitable tools and technologies to support data analysis and visualization in partnership with Data Continuum leads in Data and Computational Sciences (DCS) department

Data Stewardship: Alignment with FAIR Data Principles

  • Uphold the Findability (F), Accessibility (A), Interoperability (I), and Reusability (R) of data by promoting adequate data infrastructure, tools, and standards such as ontologies and mappings.

  • Define Data quality rules at the source system, spearheading improvements identified from the FAIR maturity and Data Quality indicators to bolster data integrity and usability​​.

Compliance with Data Standards:

Lead the implementation and monitoring of best practices and Standard Operating Procedures (e.g., naming conventions for product entities, batch numbering, analytical methods, …) within their area, ensuring adherence to Sanofi's data standards.

Digital & Data Services:

  • Advise management and data governance lead on improvement opportunities to enhance digital and data services, based on insightful analysis and a deep understanding of digital transformation strategies.

  • Communicate and stimulate the use of available services by researchers, fostering a collaborative and data-driven research environment.

About you

Experience :

  • A minimum of 5 years of professional experience within a vaccine, or biopharmaceutical domain focused on CMC process development required

  • A minimum of 2 years of experience in handling large sets of data generated across the value chain of product development and commercialization, performing advanced data analysis, leading digital transformation, or a similar role, within the biopharmaceutical industry required

Technical Skills

  • Proficient understanding of FAIR data principles, data standards, and digital transformation strategies

  • Strong knowledge of biopharmaceutical R&D domain and metadata across Research, CMC, Clinical, Regulatory

  • Solid understanding of data management, data analysis, and data pipelines

  • Practical experience or knowledge of contextualizing domain data

  • Experience in big data infrastructure and data warehouse

Soft Skills

  • Foster a culture where data is valued and readily accessible for making informed decisions

  • Proven skills in leading complex projects in an international environment

  • Resourcefulness and ability to initiate, design, and direct creative solutions to problems

  • Proven ability to independently drive process harmonization and data standardization

  • Inspiring and collaborative leadership style with the ability to motivate and influence others

  • Exceptional ability to communicate technical concepts to diverse audiences

  • Experienced in working in an agile environment

Education

  • BS in life sciences, Engineering, Biotechnology, Chemistry, Computer Science, or equivalent degree required. MS degree is preferred.

Languages:

  • Excellent knowledge of the English language (spoken and written)

  • 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

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

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