Principal Process Engineer Technical Sciences

Principal Process Engineer Technical Sciences

Sanofi

Geel, Belgium

About the job

As a Principal Process Engineer Technical Sciences within our MSAT Recombinant Drug Substance Global Platform function, you'll drive lifecycle management activities for end-to-end manufacturing processes and provide critical technical support for commercial products. The Technical Sciences Group within our function owns lifecycle management of commercial manufacturing processes within Sanofi's Manufacturing and Supply network, covering an expansive portfolio of 17 products, 5 modalities, and 3 expression systems across 12 internal and external global sites in the US and EU. You'll support the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion proteins, and antibody-drug conjugates, while working with recently established second-generation manufacturing processes featuring continuous process platforms. Ready to get started?

Main responsibilities

• Drive lifecycle management activities for end-to-end recombinant drug substance manufacturing processes at contract manufacturing organizations (CMOs) by partnering closely with CMO technical teams and Sanofi's External Manufacturing groups;
• Provide technical support to commercial products throughout their lifecycle, including routine process monitoring, person-in-plant technical oversight, investigations, critical deviations resolution, and process changes;
• Acts as an internal recipient of the technology transfer (CMO is the external recipient) and takes process ownership after successful transfer;
• Review manufacturing processes, development and production data, continuous process verification (CPV) plans and reports to identify trends and risks;
• Lead investigations and provide data analysis for critical deviation resolution, applying root cause analysis and risk assessment methodologies;
• Recommend and implement continuous improvement initiatives to enhance quality, productivity, recovery, and overall efficiency, leveraging Sanofi's digital tools;
• Lead technical project teams and provide mentorship and technical guidance to less experienced colleagues;
• Partner with cross-functional teams including Engineering, External Manufacturing, External Quality groups, and other MSAT groups, to design experiments, interpret results, and recommend next steps;
• Champion the use of digital tools as part of lifecycle management initiatives and oversee reporting on manufacturing robustness and key performance indicators (KPIs).

About you

• Educational background in engineering or science (Bachelor's, Master's, or PhD level);
• Experience in biotechnology or pharmaceutical manufacturing;
• Drug Substance (DS) manufacturing experience;
• High level of technical expertise and hands-on experience in mammalian cell culture and/or protein purification techniques;
• Strong analytical and problem-solving skills, including root cause analysis and risk assessment;
• Excellent communication skills, including technical writing and ability to engage senior stakeholders;
• Comfortable working in cross-functional, global, and matrixed environments;
• Willingness to travel (up to 30%) and support manufacturing operations flexibly on an ‘on call’ 24/7 basis.