Sanofi US
Principal Process Engineer-Technical Sciences
Sanofi US, Framingham, Massachusetts, us, 01704
Overview
Job Title:
Principal Process Engineer-Technical Sciences Location:
Framingham, MA We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 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, driving life cycle initiatives and providing commercial manufacturing support, both internally and at CMOs. The function also supports tech transfer activities including process fit-gap assessment, process validation, PAI support, technical troubleshooting and continuous improvement initiatives. Our 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, and antibody-drug conjugates. We have established second-generation manufacturing processes with a continuous process platform and pursue future innovations such as digital labs, factory of the future and analytics-based process understanding and control. At Sanofi, we promote Environmental Sustainability by Design through an eco-design approach and will drive the strategic direction of Environmental Sustainability initiatives across the organization. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We offer opportunities to grow your career, connect with people, and stretch the limits of what you thought possible. Main Responsibilities
Drives Life Cycle Management (LCM) activities of end-to-end recombinant DS manufacturing processes at CMOs, partnering with CMO technical teams and 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 communicates with the relevant technical product team. Performs reviews of manufacturing processes, deviations, and development/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 to solve complex problems. Leads small technical project teams and provides guidance to less experienced staff. Works with other MSAT groups to design experiments, interpret results, and recommend changes or additional experiments. Partners with colleagues and CMOs from Engineering, External Manufacturing and External Quality groups. Advocates the use of digital tools as part of LCM initiatives. Oversees and reports on overall manufacturing robustness and relevant KPIs. About You
Basic Qualifications
Bachelor’s degree in engineering or science with 5 years of experience OR Master’s degree in engineering or science with 3 years of experience OR PhD in engineering or science 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; develop self and others for 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 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 Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Grow your talent and drive your career, whether through promotion or lateral moves, at home or internationally. Enjoy a rewards package that recognizes your contribution and amplifies your impact. Take care of yourself and your family with health and wellbeing benefits, including high-quality healthcare and parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #Onsite #vhd Pursue progress, discover extraordinary. Better medicines, better outcomes, better science. Progress happens when people from diverse backgrounds come together. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com. US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
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Job Title:
Principal Process Engineer-Technical Sciences Location:
Framingham, MA We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 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, driving life cycle initiatives and providing commercial manufacturing support, both internally and at CMOs. The function also supports tech transfer activities including process fit-gap assessment, process validation, PAI support, technical troubleshooting and continuous improvement initiatives. Our 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, and antibody-drug conjugates. We have established second-generation manufacturing processes with a continuous process platform and pursue future innovations such as digital labs, factory of the future and analytics-based process understanding and control. At Sanofi, we promote Environmental Sustainability by Design through an eco-design approach and will drive the strategic direction of Environmental Sustainability initiatives across the organization. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We offer opportunities to grow your career, connect with people, and stretch the limits of what you thought possible. Main Responsibilities
Drives Life Cycle Management (LCM) activities of end-to-end recombinant DS manufacturing processes at CMOs, partnering with CMO technical teams and 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 communicates with the relevant technical product team. Performs reviews of manufacturing processes, deviations, and development/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 to solve complex problems. Leads small technical project teams and provides guidance to less experienced staff. Works with other MSAT groups to design experiments, interpret results, and recommend changes or additional experiments. Partners with colleagues and CMOs from Engineering, External Manufacturing and External Quality groups. Advocates the use of digital tools as part of LCM initiatives. Oversees and reports on overall manufacturing robustness and relevant KPIs. About You
Basic Qualifications
Bachelor’s degree in engineering or science with 5 years of experience OR Master’s degree in engineering or science with 3 years of experience OR PhD in engineering or science 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; develop self and others for 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 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 Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Grow your talent and drive your career, whether through promotion or lateral moves, at home or internationally. Enjoy a rewards package that recognizes your contribution and amplifies your impact. Take care of yourself and your family with health and wellbeing benefits, including high-quality healthcare and parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #Onsite #vhd Pursue progress, discover extraordinary. Better medicines, better outcomes, better science. Progress happens when people from diverse backgrounds come together. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com. US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
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