Principal Process Engineer-Technical Sciences

Sanofi•Framingham, MA

50d

About The Position

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"

Requirements

Bachelor's degree in engineering or science with 10+ years of experience in a tech transfer/tech support for DS manufacturing
Master's degree in engineering or science with 8+ years of experience of experience in a tech transfer/tech support for DS manufacturing
PhD in engineering or science with 4+ years of experience of experience in a tech transfer/tech support for DS manufacturing
Act for Change: embrace change and innovation and initiate new and improved ways of working.
Cooperate transversally: collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
Lead and Develop People: Build, manage, motivate, and empower teams and workgroups. Take responsibility for developing one's self and others in anticipation of future business needs.

Nice To Haves

Experience in biotechnology or the pharmaceutical industry
Experience in purification, cell culture, or analytical methods
Experience with root cause analysis and/or risk assessment
Knowledge of DeltaV automation
Experience working with statistical analysis software
Experience providing solutions for difficult technical issues
Experience communicating with senior management
Strong technical writing and communication skills
Experience with high level data analysis
Experience with project leadership
Experience communicating with cross functional teams
Proficient in Microsoft Word, Excel, PowerPoint

Responsibilities

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.

Benefits

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.

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