Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job Title: Senior Program Leader

Location: Morristown, NJ or Cambridge, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

The strategic vision of Sanofi’s Global Medical Device and Packaging organization is to lead the industry in device-mediated therapies, with the ambition to develop, launch and maintain best-in-class drug-delivery systems and connected medical devices that address patient unmet needs and improve health outcomes. Our specific mission is to support R&D and the Sanofi Commercial Business Units by delivering differentiated technology solutions that enhance the value of our drugs and vaccines and help patients (and health care providers) facilitate administration, thereby improving their quality of life and empowering them to take control of their disease. Our products and solutions sit on top of our market leading technology platforms, are user-centric, innovative, environmentally sustainable, producible in high quantities and are continuously improved to meet evolving needs.   

We continue to recruit top talent in the industry to help transform the standard of care in the areas of drug delivery devices and stand-alone medical devices.  Our teams have developed and released to market auto-injectors, pens, safety syringes, as well as connected medical device technologies and we are in a mode to continue ramp up the volumes and re-new with industry standard and innovative solution our device manufacturing capacities.

Within Sanofi`s Global Device and Packaging Unit, as senior program leader you will play a pivotal role in leading programs covering all aspects of device and packaging (primary and secondary) for your products, either in development or in Life cycle management.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• You will lead a cross-functional team which combines multidisciplinary functions, including GDPU and GDPQ, QA/RA, M&S Site and global functions, MSAT, CMC teams and external partners, assigned to the program. 

• With your team members, you will build and deploy a robust product strategy, addressing essential aspects related to Device and Packaging of the pharmaceutical product, and process engineering, project/program management, quality, regulatory and supply.

• This role requires a strategic thinker with cross-functional perspective, and a deep technical expert who can drive programs from concept to commercialization.  

• This role involves close collaboration with R&D (for development) and M&S (for industrialization and LCM) to deliver device and packaging technologies that enhance the value of the drug and provide competitive advantage. 

• You may   partner directly with the Global Project Head (for development) and/or Industrial Product Leader (for LCM) integrating their team as needed, business, CMC key stakeholders, suppliers and within M&S (M&S Sites, , MSAT) to ensure robust and aligned clinical, marketing, and regulatory strategies. 

• You will represent GDPU for the program in all cross-functional meetings and ensure that strategy, scope, plan, and budget, is fully understood by all stakeholders and aligned in advance of governance body meetings. For projects for which the device component is core, represent GDPU directly, ensuring that device aspects are covered explicitly into a specific section. 

• You may be assigned for LCM as Site Network Coordinator, acting as GDPU reference point for a given network of M&S sites, involved in manufacturing of your products.

You will also:

• Support GPT and IPT to define product vision; analyze market, the users, and the roadmap for the product. 

• Translate the overall project strategy into a product development plan (development scope) or an industrialization, packaging & device performance maintenance plan (LCM scope) with clear scope, schedule, resources, budget (Supplier Selection, and Industrialization Equipment) and execute accordingly.

• Set a high bar for team to push the boundaries, by balancing risk with rigor to optimize and scale program based on scope, complexity and risk.

• Oversee program through completion of milestones following a regulated, structured process and appropriate governance.  

• Work with the project managers to develop, industrialize and launch plans for your products. Develop and follow, supported by project managers, key KPIs to drive performance excellence and improvements through management of budget, schedule delivery, and scope.

• Ensure Product Stewardship for your product, fostering within your team product knowledge accumulation and transfer. LCM portfolio will mainly support M&S organization and Development portfolio will mainly support R&D.

• Develop a strong network and partnership with M&S, IPL, External Partners, Quality, Regulatory, Supply chain, Procurement, Commercial, R&D and ensure strong stakeholder ties and management by influencing and ensuring fluid communication regarding project/program objectives, priorities, progress, and critical issues.   

• If assigned to a role of Site Network Coordinator in the LCM portfolio, act as first contact for network sites in case for issue troubleshooting and escalation, Lead the Site Network Core and Extended team and organize regular Device and Packaging Site Network Exchange meetings.

• Stay abreast of the technology and Regulatory landscape and compliance standards applicable to the global target markets of Sanofi’s device portfolio, to ensure seamless projects and product compliance with industry standards and regulations (Product maintenance)   

• Actively participate as a member of GDPU portfolio Team and related governance bodies, contributing to strategic discussions and decision-making processes. 

Skills:  

• Ability to think strategically, creatively, and purposefully while managing multiple projects. 

• Strong business acumen and ability to evaluate changing business conditions and effectively shift strategy and priorities based on dynamics. 

• Active role model of Play To Win and enabler of PTW Strategy

• Strong leadership and communication skills with ability to work effectively in a complex, matrixed global organization, leveraging solid influencing and collaboration skills. 

• Agile thinker and learner, highly adaptable to a dynamic environment. 

• Ability to build, inspire, and lead high performing autonomous teams that can stretch and bring value to the organization and our patients. 

• Leadership courage and role model of Sanofi core values  

• Strong technical aptitude, analytical thinking, and ability to distil complex problems to simple solutions.  

• Strong technical judgement. Ability to anticipate risks and challenges and guide team to develop strategic solutions to overcome or prevent obstacles in the development process. 

About You 

Basic Qualifications:

• BS or MS in a Scientific discipline, Engineering (mechanical, electromechanical, medical technology, plastics, physics, or related field) or an MBA.

• Minimum 8+ years in medical device or combination product development, industrialization, or manufacturing within a pharmaceutical, biotechnology or medical device arena is required.

• Demonstrated leadership experience in managing cross-functional teams in bringing medical devices from concept to commercialization.

• Experience with regulatory agencies or notified bodies, e.g., FDA, EMA or TUEV and solid knowledge of key regulatory requirements in the industry (21 CFR parts 4 & 820, ISO13485 and other related industry standards) is required.

• Expert systems engineering (drug device integration, sub-systems) and integration of multiple disciplines into a product development, able to lead and coach others and drive standard process development in this field.

Preferred Qualifications

• Additional experience with establishing and managing of activities at third party manufacturers, vendors and/or with partnerships in a global environment is strongly preferred but not required.​

• International leadership and business experience.

• Experienced in operational and financial responsibilities as well as resource allocation for on time and on budget delivery.

• Experienced and qualified in project management activities (e.g., PMP)

• Good knowledge of manufacturing sciences and technologies

Languages:

• Basic knowledge of French or German 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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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.