Principal Process Engineer-Technical Sciences

Job Title: Principal Process Engineer-Technical Sciences

Location: Framingham, MA

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.

The Technical Sciences Group within MSAT Recombinant DS Global Platform function is the owner of Life Cycle Management of commercial manufacturing processes within Sanofi Manufacturing and Supply network. We are the process owners of commercial manufacturing processes, we drive life cycle initiatives and provide commercial manufacturing support, both internally and at CMOs. The function is also responsible for supporting tech transfer activities including process fit-gap assessment, process validation, PAI support, technical troubleshooting and drive continuous improvement initiatives.

Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates. In recent years we have successfully established second-generation manufacturing processes with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.

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 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

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

• Drives LCM activities of end-to-end recombinant DS manufacturing processes at CMOs, by partnering with the CMO technical teams and with Sanofi External Manufacturing groups.

• Provides technical support and routine process monitoring for commercial products

• Provides person-in-plant technical oversight of manufacturing operations at CMOs and communication to the relevant technical product team.

• Performs the reviews of manufacturing processes, critical deviations, and/or development and production data.

• Provides technical support and data analysis for investigations and critical deviations resolution.

• Recommends and drives continuous improvement initiatives to enhance quality, productivity, recovery, and overall efficiency through Sanofi digital tools.

• Demonstrates solid understanding and use of engineering principles and practices to solve a range of complex problems in creative and practical ways.

• Leads small technical project teams · and provides technical guidance to less experienced staff 

• Works with other MSAT groups (internal or CMO) to design necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments

• Partners with colleagues and CMOs from various functions, such as Engineering, External Manufacturing and External Quality groups.

• Shepherds the use of digital tools as part of the LCM initiatives.

• Oversees and reports on overall manufacturing robustness and relevant KPIs.

About You

Basic Qualifications

• Bachelor’s degree in engineering or science with 10+ years of expe