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mRNA Analytical Data Transformation Lead - Vaccines

Principia Biopharma, Inc.

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Waltham, MA
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Job Description

As posted by the hiring company

Job Overview:

Job title: mRNA Analytical Data Transformation Lead -Vaccines

Location: Waltham, MA

About the Job

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.

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 Analytical Science department in mRNA CoE is to develop adequate analytical methods, test product including pDNA, mRNA, LNP and Drug Product to support R&D pipeline from Phase 1 to licensure. Analytical Sciences has laboratory capabilities in France and US where more than 100 scientists, engineers, and technicians are generating, and capturing a large amount of data. Embedded within Analytical Sciences department, you will work closely with analytical 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 Analytical Science and with counterparts in PD&I, R&B and Data and Computational Science (DCS) departments.

Main Responsibilities:

Business Processes Standardization

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

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

  • Collaborate with counterparts in PD&I and R&B deparments to drive data process harmonization, and implementing 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

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 business policies 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

  • Bachelor's degree in life sciences, Engineering, Biotechnology, Chemistry, Computer Science or equivalent degree required. Master's degree is preferred.

  • 5+ years of professional experience in the vaccine, or biopharmaceutical domain focused on Analytical Sciences required.

  • 2+ years of experience handling large sets of data, performing advanced data analysis, leading digital transformation, or a similar role, within biopharmaceutical industry required.

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

  • Strong knowledge of biopharmaceutical R&D data, data domain across Research, CMC, Clinical, Regulatory and metadata is highly helpful.

  • Practical experience or knowledge of UPLC/HPLC coupled with UV detection, LC-CAD, LC-MS; Capillary electrophoresis; SDS-PAGE; Colorimetric analyses; DLS; ELISA, qPCR, ddPCR, Sanger sequencing is strongly preferred.

  • Ability to 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

  • Exceptional ability to communicate technical concepts to diverse audiences

  • Experienced in working in an agile environment

  • Sensitivity to Quality and HSE aspects.

  • Excellent knowledge of English language (spoken and written). 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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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.