Head of Scientific Excellence

Location: Framingham, MA

Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year.

The Head of Scientific Excellence provides scientific expertise to accelerate technical modernization for product commercialization within the MSAT Recombinant Drug Substance (DS) platform. Core platform activities include product transfers, process monitoring, validation, material management, facility design and CMC requirements.

The role will provide scientific expertise supporting CMC regulatory guidance with innovative approaches to process and analytical comparability, whilst supporting product technical teams to assess risk, probability of success and change management strategies. The role will support the platform implementation and excellence for modernization initiatives. In addition, the role will have responsibility for material sciences to drive improvements in material quality and leverage supplier partnerships for MSAT activities with consideration of eco-design.

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:

• Provide Scientific Expertise to advance CMC comparability strategy and approaches to enable health authority acceptance with evolving regulatory practices and guidance.

• Provide structured approach for modernization initiatives to drive platform excellence for key activities supporting new product introduction and 2nd generation products.

• Material Sciences leadership to drive improvements in material quality and testing standardization (L&E). Leverage supplier partnerships for accelerating technical innovation and efficiency gains for technical project provision.

• Provide oversight on strategies and approaches for cell bank management including testing, qualification and supply security.

• At Sanofi, we have charted a clear path forward to not only minimize the environmental impact across our value chain but also adapt our business to the environmental challenges that we face, promoting Environmental Sustainability by Design through our eco-design approach. This role will drive and execute the strategic direction of Environmental Sustainability by Design initiatives with the organization, fostering a culture of environmental sustainability and innovation in pharmaceutical development.

About You

Education:

• PhD/Master’s degree in Life Sciences and/or Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy, or related.

Experience:

• 10+ years of broad and long-term experience in the biotech/ pharmaceutical industry, specifically in R&D and/or MSAT (industrial development) with manufacturing cGMP considerations, and global CMC projects.

• 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions.

• 5+ years of leadership experience - Proven capabilities to lead a cross-functional team in a matrix organization. Global exposure and stakeholder management experience.

• Experience with material management including evaluation, change control and testing.

• Specialist knowledge in one or more areas; material sciences, Single-Use technologies (SUT), technical process or analytical platform evaluation.

• Preferred experience with cell bank qualification and management.

• Strong scientific background in biological process development (mammalian and/or microbial) and/or product analytics.

• Good understanding of cGMP requirements and facility operations.

• High experience in exposure to change management and transversal collaboration

Soft skills

• Proven capabilities to lead a cross-functional team in a matrix organization. Global exposure and stakeholder management experience.

• Able to lead and animate networks, teams, experts - Excellent communication and interpersonal skills, stakeholder management skills.  

• Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities. 

• Results orientation: Demonstrated ability to drive initiatives from concept to execution.

• High level of autonomy. Comfortable with ambiguity and adapts with high agility. 

• People development: Engages and leverages everyone’s strengths while being highly self-aware. Ability to set ambitious goals, communicate & align priorities across the organization. 

• Relationship & Influence: able to manage ambiguity and partners without solid reporting line. Ability to influence outside M&S (CMC Dev, Finance and global regulatory) 

• Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks. 

• Commit to patients and full product quality. Makes sure the teams understand how to act for patients and customers. 

• Issue resolution and decision-making skills.

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.