Head of US Large Scale Biologics Program - Factory of the Future

Job Title: Head of US Large Scale Biologics Program - Factory of the Future

Location: Morristown, NJ

About the job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 

Our Team:

Strategic Context: This role is pivotal to Sanofi's US manufacturing strategy and represents a landmark investment in US biopharmaceutical manufacturing. The facility was secured through strategic agreements with the US Administration as part of broader trade and manufacturing policy discussions. Success requires not only technical excellence but also sophisticated stakeholder management with federal, state, and local government entities. This is Sanofi's flagship "Factory of the Future" - setting the standard for biologics manufacturing globally for the next two decades.

The Large Scale Biologics (LSM) Program Head is in charge of leading the LSM project constituted of:

• Standard design in term of process, automation, digital and operating model

• Green/Brown - field Large Drug Substance Scale Mabs Facility in US

• Coordination of all activities associated, from design to start-up with the setup of the new drug substance manufacturing buildings.

• He/she represents SpeCare M&S in the overall project, working in very close collaboration with global functions, R&D, External Affairs US. He/she is part of SpeCare M&S Leadership Team.

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:

• Strategic Leadership & External Relations:

  • Leading strategic engagement with US federal, state, and local government stakeholders, ensuring alignment with commitments made during trade policy negotiations and maintaining strong relationships with the US Administration

  • Serving as Sanofi's primary representative for this flagship investment, articulating the strategic vision to external stakeholders including government officials, regulatory authorities, community leaders, and industry partners

  • Representing the program before regulatory authorities (FDA, EMA, ANSM, WHO, NMPA) throughout all project phases

• Program Execution & Delivery:

  • Providing overall leadership and direction to the brownfield/greenfield project team (~2000+ staff at peak), ensuring manufacturing facilities and equipment are properly designed, installed, qualified, and validated

  • Ensuring on-time, on-budget execution of this ~$2B program with rigorous risk management, mitigation planning, and executive reporting

  • Delivering CapEx frugality and COGS optimization - accountable for achieving best-in-class efficiency metrics

  • Ensuring the facility meets all performance targets committed in the SPE and embodies "Factory of the Future" principles

• Quality, Safety & Compliance:

  • Ensuring all Safety & Quality Standards and Regulatory commitments are met with the highest standards of excellence

  • Ensuring thorough knowledge and application of cGMP and regulatory requirements throughout all project phases

  • Managing multiple Pre-Approval Inspections (FDA, EMA) successfully

• Operational Readiness & Integration:

  • Building and executing manufacturing staffing and training plans (300+ operational staff) along project execution through to routine operations

  • Leading strategic workforce planning and talent development for this flagship facility

  • For Greenfield: Completing all activities to establish a new US site (land acquisition, permitting, organizational design, community integration)

  • For Brownfield: Ensuring seamless integration of the new production unit within the existing campus

• Technical Excellence & Innovation:

  • Partnering with Engineering, R&D and MSAT to optimize process definition for new equipment and facility, ensuring process robustness, product quality, and cost optimization

  • Delivering a fully digitalized facility (40+ digital applications) that serves as Sanofi's digital lighthouse for biologics manufacturing

  • Providing manufacturing schedules supporting project execution and production ramp-up to routine operations

About you

Experience / Education / Skills:

• Proven track record engaging with US federal and state government officials, with demonstrated ability to navigate complex political and regulatory environments 

• Master’s degree in Life Sciences, Engineering, or Biotechnology is preferred

• Experience managing large-scale capital projects ($500M+) in highly regulated industries

• Strategic business acumen with ability to balance technical excellence, financial discipline, and stakeholder expectations

• Experience with public-private partnerships or government-supported industrial projects (highly desirable)

• Track record of delivering "first-of-kind" or flagship facilities

• Strong collaboration skill to partner with the Project Engineering leader 

• Comfortable in working with MATRIX nature of the project team

• Broad industrial experience in the pharmaceutical business (>15 years)

• A minimum of 12 years of experience in managing and leading large teams (+100 people) within a pharma / bio environment is required

• Experience in multi-site operations, global projects and matrix management is highly preferred

• Thorough knowledge of cGMP and regulatory requirements

• Demonstrated ability to build highly performing teams

• Exceptional stakeholder management skills with specific experience engaging US federal/state administrations, congressional offices, and economic development agencies

• Demonstrated “Take the Lead” behaviours.

• Recognized ability to deliver results set by the organization, in partnership with colleagues and support functions, in a win-win spirit, with examples in terms of safety and quality performance enhancement, cost and cycle time reduction, project execution, etc.

• Demonstrated experience interfacing with Governmental agencies and regulatory boards.

• Fluent in English (French is a plus)

• Strive to result and ability to make decision in a complex and high-speed environment.

• Intercultural experience

• Excellent communication skills

Travel Requirements

• This position may require up to 35% overall business travel

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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.