Digital R&D Product Owner
Sanofi Group, Watertown, MA, United States
Job title:
Digital R&D Product Owner
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 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.
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.
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.
Business stakeholders Management & partnership:
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.
GMP Compliance & 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
About You
Education & Experience
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
Technical Expertise
Deep understanding of GMP/regulatory requirements and pharmaceutical quality systems
Knowledge of laboratory automation, LIMS/ELN systems, and analytical data management
Core Skills
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 have Qualifications
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
Why Choose Us
:
Bring the miracles of science to life alongside a supportive, futurefocused team.
Discover endless opportunities to grow your talent and drive yourcareer, whether it's through a promotion or lateral move, at home orinternationally.
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 EmployeeResource 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.
#GD-SA
#LI-SA
#vhd
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) !
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:
$133.500,00 - $192.833,33
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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
Digital R&D Product Owner
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 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.
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.
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.
Business stakeholders Management & partnership:
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.
GMP Compliance & 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
About You
Education & Experience
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
Technical Expertise
Deep understanding of GMP/regulatory requirements and pharmaceutical quality systems
Knowledge of laboratory automation, LIMS/ELN systems, and analytical data management
Core Skills
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 have Qualifications
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
Why Choose Us
:
Bring the miracles of science to life alongside a supportive, futurefocused team.
Discover endless opportunities to grow your talent and drive yourcareer, whether it's through a promotion or lateral move, at home orinternationally.
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 EmployeeResource 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.
#GD-SA
#LI-SA
#vhd
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) !
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:
$133.500,00 - $192.833,33
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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)