Principal Process Engineer-Technical Sciences

Role Summary

Principal Process Engineer-Technical Sciences at Framingham, MA. Lead Life Cycle Management of commercial recombinant DS manufacturing processes, provide technical support for CMOs, and drive continuous improvement and environmental sustainability initiatives within Sanofi Manufacturing and Supply.

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.

Qualifications

• Bachelor‚Äôs degree in engineering or science with 10+ years of experience in a tech transfer/tech support for DS manufacturing
• Master‚Äôs 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

Leadership Qualifications

• 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‚Äôs self and others in anticipation of future business needs.

Preferred Qualifications

• 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

Special Working Conditions

• Up to 35% Travel requirement
• Ability to gown and gain entry to manufacturing areas
• Support manufacturing operations on an "on call" 24/7 basis