Technical Lead - Samsung Biologics

Department Descriptions 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” Key Responsibilities This role is the technical person in plant at the CMO in Asia, where Sanofi has contracted clinical and/or commercial manufacturing operations. The incumbent will represent Sanofi at the CMO and will have the following responsibilities: · Drive LCM activities of end-to-end rec DS manufacturing processes at CMOs, by partnering with the CMO technical teams and with Sanofi External Manufacturing groups. · Provide technical support and routine process monitoring for commercial products · Provide person-in-plant technical oversight of manufacturing operations at CMOs and communication to the relevant technical product team. · Perform the reviews of manufacturing processes, critical deviations, and/or development and production data. · Provide technical support and data analysis for investigations and critical deviations resolution. · Recommend and drive continuous improvement initiatives to enhance quality, productivity, recovery, and overall efficiency through Sanofi digital tools. · Demonstrate solid understanding and use of engineering principles and practices to solve a range of complex problems in creative and practical ways. · Lead small technical project teams · and provides technical guidance to the CMO MSAT staff · Work with other MSAT groups (internal or CMO) to design necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments · Partner with colleagues and CMOs from various functions, such as Engineering, External Manufacturing and External Quality groups. · Shepherd the use of digital tools as part of the LCM initiatives. · Oversee and report on overall manufacturing robustness and relevant KPIs. Basic Qualifications · Bachelor’s degree in engineering or science with 10 years of experience OR · Master’s degree in engineering or science with 8 years of experience OR PhD in engineering or science with 5 years' experience Leadership Qualifications Cooperate transversally : collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results. 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 20% International Travel requirement Ability to gown and gain entry to manufacturing areas Support manufacturing operations on an "on call" 24/7 basis Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. 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