Job title: Digital R&D Product Owner
• Location: Framingham, MA Location: Framingham, MA
About the Job
As Digital R&D Product Owner within our Digital team , you will be part of the iCMC Digital Transformation, a global top initiative that aims at building competitive CMC capabilities and enabling a digital continuum for R&D and M&S data. This is a unique program implementing an ambitious Digital Transformation across process development activities in R&D and M&S, with over 2,500 users across 10+ countries.
The iCMC Digital Transformation initiative is implementing cutting-edge digital technologies to build our next generation of data centralization and data consumption platforms, including paperless CMC labs with end-to-end automated data flows to improve productivity and cycle times, digitized intra- and inter-laboratory workflows to ensure data accessibility and integrity for GMP and non-GMP labs, advanced analytics to optimize key CMC activities leveraging AI/ML agents and modeling platforms, and a foundation for a Digital Continuum from research to development to manufacturing for all our products and processes.
The Digital R&D Product Owner for end-to-end GMP analytical data flows will own, deliver, manage, and optimize the digital solutions for GMP R&D analytical labs, from lab instruments to data capture, data categorization, and data visualization, until its transfer and/or interfacing with Manufacturing, Quality Management, and R&D QC LIMS as part of Sanofis Digital ecosystem.
Business processes covered include end-to-end workflow for GMP-compliant analytical (DS/DP) laboratory solutions across Sanofis R&D Bioanalytics, Synthetics, Vaccines/mRNA, and MSAT teams, including generation of Certificate of Analysis and Stability Reporting. This important role will drive digital transformation globally, accelerating analytical workflows while ensuring regulatory compliance and delivering measurable value to patients.
Join the digital engine driving Sanofi's transformation - where AI, automation, and bold experimentation power faster science and smarter decisions. Here, you'll help build the first biopharma company powered by AI at scale.
About Sanofi
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities
Product Strategy & Delivery
• Be accountable for ensuring high-quality of E2E data flows delivered for GMP analytical labs from lab instruments to data capture, data categorization and data visualization, until its transfer and/or interfacing with Manufacturing, Quality Management and R&D QC LIMS systems part of Digital ecosystem. Be accountable for ensuring high-quality of E2E data flows delivered for GMP analytical labs from lab instruments to data capture, data categorization and data visualization, until its transfer and/or interfacing with Manufacturing, Quality Management and R&D QC LIMS systems part of Digital ecosystem.
• Ensure features developed are aligned with core products strategy & best practices, data flows architecture and aligned with Digital strategy. Ensure features developed are aligned with core products strategy & best practices, data flows architecture and aligned with Digital strategy.
• Manage complete product lifecycle from ideation through retirement, including E2E support of the product implementation with Agile teams and/or support teams in a GMP compliance context Manage complete product lifecycle from ideation through retirement, including E2E support of the product implementation with Agile teams and/or support teams in a GMP compliance context
• Develop roadmaps aligned with R&D priorities and regulatory requirements Develop roadmaps aligned with R&D priorities and regulatory requirements
• Identify inter dependencies with other GMP Products (ex: QC LIMS, LES) and manufacturing systems & work closely with manufacturing team, and digital M&S to smooth tech transfer between R&D and Manufacturing & bridge analytical development and manufacturing scale-up Identify inter dependencies with other GMP Products (ex: QC LIMS, LES) and manufacturing systems & work closely with manufacturing team, and digital M&S to smooth tech transfer between R&D and Manufacturing & bridge analytical development and manufacturing scale-up
• Accountable for building robust interfaces between analytical systems and manufacturing platforms working closely with Technical delivery teams and Digital Architecture Accountable for building robust interfaces between analytical systems and manufacturing platforms working closely with Technical delivery teams and Digital Architecture
• Prepare & facilitate stage gate for your product as part of the Digital R&D governance. Prepare & facilitate stage gate for your product as part of the Digital R&D governance.
Business stakeholders Management & partnership:
• Work closely in partnership with R&D analytical labs teams across Sanofis R&D Bioanalytics, Synthetics, Vaccines/mRNA, and MSAT organizations to ensure digital solutions proposed are meeting users' needs Work closely in partnership with R&D analytical labs teams across Sanofis R&D Bioanalytics, Synthetics, Vaccines/mRNA, and MSAT organizations to ensure digital solutions proposed are meeting users' needs
• Work closely with Digital R&D product teams & Delivery engines teams to ensure equipment connectivity, methods development, data integration and visualization as well as interfaces are delivered on a timely basis and high quality. Work closely with Digital R&D product teams & Delivery engines teams to ensure equipment connectivity, methods development, data integration and visualization as well as interfaces are delivered on a timely basis and high quality.
GMP Compliance & Quality
• Accountable for data integrity, traceability, and GxP compliance throughout the analytical-to-manufacturing pipeline Accountable for data integrity, traceability, and GxP compliance throughout the analytical-to-manufacturing pipeline
• Ensure digital solutions meet GMP, GLP, and regulatory standards (FDA, EMA, ICH) Ensure digital solutions meet GMP, GLP, and regulatory standards (FDA, EMA, ICH)
• Drive data integrity, traceability, and ALCOA+ principles in all digital workflows Drive data integrity, traceability, and ALCOA+ principles in all digital workflows
• Partner with Quality Assurance, Regulatory Affairs, and Digital Risk & Compliance teams on validation strategies Partner with Quality Assurance, Regulatory Affairs, and Digital Risk & Compliance teams on validation strategies
• Maintain audit readiness across all analytical systems Maintain audit readiness across all analytical systems
• Establish governance frameworks for cross-product integration and data exchange Establish governance frameworks for cross-product integration and data exchange
About You
Education & Experience
• Bachelor degree in computer sciences or engineering or Life Sciences/ Bioprocess Engineering/Chemical Engineering or related field. Bachelor degree in computer sciences or engineering or Life Sciences/ Bioprocess Engineering/Chemical Engineering or related field.
• 5+ years of pharmaceutical analytical development experience in GMP, with at least 3 of those years as a Product Owner or Product Manager 5+ years of pharmaceutical analytical development experience in GMP, with at least 3 of those years as a Product Owner or Product Manager
Technical Expertise
• Deep understanding of GMP/regulatory requirements and pharmaceutical quality systems Deep understanding of GMP/regulatory requirements and pharmaceutical quality systems
• Knowledge of laboratory automation, LIMS/ELN systems, and analytical data management Knowledge of laboratory automation, LIMS/ELN systems, and analytical data management
Core Skills
• Agile Methodology: Scrum, Kanban, product development Agile Methodology: Scrum, Kanban, product development
• Knowledge or experience on Digital Product Management or product Ownership Knowledge or experience on Digital Product Management or product Ownership
• Stakeholder Management: Multi-disciplinary, global teams Stakeholder Management: Multi-disciplinary, global teams
• Data-Driven Decision Making: Analytics, metrics, KPIs Data-Driven Decision Making: Analytics, metrics, KPIs
• Business Acumen: Strong pharmaceutical R&D operations knowledge Business Acumen: Strong pharmaceutical R&D operations knowledge
• Quality Mindset: Commitment to excellence in regulated environments, experience in Change Control processes and system interacting with Quality team Quality Mindset: Commitment to excellence in regulated environments, experience in Change Control processes and system interacting with Quality team
Nice to have Qualifications
• Experience with Waters, Agilent, Thermo Fisher analytical platforms Experience with Waters, Agilent, Thermo Fisher analytical platforms
• Vaccines, mRNA, or biologics analytical development background Vaccines, mRNA, or biologics analytical development background
• Cloud platforms (AWS, Azure) and modern data architecture familiarity Cloud platforms (AWS, Azure) and modern data architecture familiarity
• Expertise in analytical methods (HPLC, LC-MS, spectroscopy, bioanalytical assays) Expertise in analytical methods (HPLC, LC-MS, spectroscopy, bioanalytical assays)
• Agile/PMP certification Agile/PMP certification
Why Choose Us :
• Bring the miracles of science to life alongside a supportive, futurefocused team. Bring the miracles of science to life alongside a supportive, futurefocused 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. 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. 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. 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.
• Join the digital force behind Sanofi's AI-powered pipeline, where Expert, Generative, and Snackable AI accelerate the discovery, development and delivery of breakthrough treatments to patients. Join the digital force behind Sanofi's AI-powered pipeline, where Expert, Generative, and Snackable AI accelerate the discovery, development and delivery of breakthrough treatments to patients.
• Help reduce time from discovery to commercialization, delivering life-changing medicines to patients faster than ever. Help reduce time from discovery to commercialization, delivering life-changing medicines to patients faster than ever.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice. Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
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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Pursueprogress, discoverextraordinary
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.
North America Applicants Only
The salary range for this position is:
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .