MSAT Recombinant DS Cluster Head

Job Title: MSAT Recombinant DS Cluster Head

Location: Framingham, 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.

Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfils an important function by providing day-to-day Manufacturing Support, focusing on technical and process aspects, effective Life Cycle Management, process robustness enhancement, and yield improvements to optimize performance.

Join our global network and contribute to the launch of 3 to 5 new products annually across various modalities, enabling us to reach and serve more patients and communities. Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi’s best-in-class ambition.

The MSAT Product Cluster Head serves as the primary contact for key stakeholders regarding product-related inquiries and challenges. They collaborate with Industrial Strategy leads to develop business cases supporting technical product roadmaps. These leaders oversee the complete technical lifecycle management portfolios spanning from seed/cell bank development through drug substance production, analytical processes, and drug product fill operations for their designated product clusters. As the accountable MSAT representative, they ensure prompt and effective technical support to both internal and external manufacturing facilities within their product domain. The role involves implementing technical improvement strategies that align with Manufacturing & Supply strategic objectives.

Additionally, they support new product industrialization, validation, Pre-Approval Inspections, and address technical regulatory matters in partnership with CMC-Development teams while contributing to R&D pipeline initiatives. The MSAT Product Cluster Head represents MSAT at various strategic, governance, and technical forums. They function as the MSAT entry point for the Global Business Unit product line while providing an end-to-end perspective of their product cluster within the MSAT organization.

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.

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:

• Manages Technical Product Leads for their product cluster.

• Accountable for the MSAT E2E Technical Product Teams (TPT) for their product cluster.

• Acts as MSAT Lead within Industrial/Portfolio Product teams or equivalent with primary responsibility to ensure that there is a clear end-to-end technical agenda in the Industrial Product Plan.

• The MSAT technical voice for new pipeline products coming from CMC development/R&D until an MSAT CMC lead is appointed.

• Decision maker for end-to-end technical strategic product roadmap/industrial footprint within MSAT perimeter.

• Empowered voice to MSAT leadership for their specific product cluster, advocates for resource needs and program prioritization to MSAT LT through the Portfolio Review Forum.

• Recommends prioritization within the portfolio, as needed, and consults with functional leadership, influences other organizations (Operations, Quality, Regulatory Affairs, CMC Dev/R&D and internal and/or external Sites).

• Guides Technical Product Leads (TPLs) and other TPT members in delivering the technical end-to-end product roadmap.

• In cases of conflict, makes the final decision with TPT team’s input.

• Acts as lead when troubleshooting or escalation is required to mobilize resources needed to address product related issues to ensure business continuity.

• Escalates significant issues to Stakeholders/MSAT LT and ensures senior leadership alignment on critical technical decisions at Governance forums.

About You

Basic Qualifications:

• BS, MS, or Ph.D. in Biochemistry, Chemistry, Cellular and Molecular Biology, Chemical Engineering, or related scientific discipline (BS plus 15+ years of industry experience, MS with 10+ years of industry experience or PhD with 5+ years of industry experience).

Experience:

• Extensive experience in process development, manufacturing, or analytics.

• Experience in technical transfer of technology processes and manufacturing into regulated facilities for commercial production.

• Excellent and effective verbal and written communication skills and ability to influence at all levels across M&S and Contract Manufacturing Organizations (CMOs).

• Experience leading multi-disciplinary, matrixed teams; solid problem solver, and ability to think and work creatively to meet deadlines.

• Extensive experience and in-depth scientific/technical knowledge of products whether in process development, product development, scale-up, operations, or analytical (for example, cell culture, purification, analytical characterization, and process validation).

• End-to-end product understanding from cells/seed through drug substance to drug product fill operations.

• Compliance and/or regulatory experience with knowledge and understanding of various Boards of Health stances, requirements, and regulations.

• Experience with pre- and post-launch activities (technology transfer, process validation, comparability design, continuous process verification, health authority regulations and inspection readiness, quality systems, regulatory guidance’s, etc.).

Soft skills:

• Solid management, communication and interpersonal skills; ability to set, manage and influence individual and team goals.

• Ability to evaluate/acquire knowledge related to new process technologies, modalities, digital, etc.

• Ability to anticipate and evaluate risks and proactively provide possible mitigation plans.

• Solid technical networker and collaborator with ability to be successful in a global/matrix environment.

• Demonstrated ability to manage diverse/complex product portfolios across global manufacturing network.

• Presentation skills capable of influencing decision making at senior/stakeholder levels.

• Ability to develop people, coach, provide structured feedback.

Technical skills:

• Strong problem structuring and problem-solving skills.

• Knowledge of basic financial analysis and management accounting.

• Experience in Change Management methodologies and practical knowledge of potential transformation pitfalls

• Strong written and oral communication skills, ability to synthetise complex information and present it in digestible way.

Languages:

• English

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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