Digital R&D Product Owner

Sanofi • Waltham, MA

1d

About The Position

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 Sanofi's Digital ecosystem. Business processes covered include end-to-end workflow for GMP-compliant analytical (DS/DP) laboratory solutions across Sanofi's 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.

Requirements

• 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
• Deep understanding of GMP/regulatory requirements and pharmaceutical quality systems
• Knowledge of laboratory automation, LIMS/ELN systems, and analytical data management
• Agile Methodology: Scrum, Kanban, product development
• Knowledge or experience on Digital Product Management or product Ownership
• Stakeholder Management: Multi-disciplinary, global teams
• Data-Driven Decision Making: Analytics, metrics, KPIs
• 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

Nice To Haves

• Experience with Waters, Agilent, Thermo Fisher analytical platforms
• Vaccines, mRNA, or biologics analytical development background
• Cloud platforms (AWS, Azure) and modern data architecture familiarity
• Expertise in analytical methods (HPLC, LC-MS, spectroscopy, bioanalytical assays)
• Agile/PMP certification

Responsibilities

• 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.
• 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
• 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
• Prepare & facilitate stage gate for your product as part of the Digital R&D governance.
• Work closely in partnership with R&D analytical labs teams across Sanofi's 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.
• 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)
• 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
• Maintain audit readiness across all analytical systems
• Establish governance frameworks for cross-product integration and data exchange

Benefits

• 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.
• 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.
• 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.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level