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Senior Upstream Process Engineer, MSAT

Framingham, Massachusetts

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Responsibilities

Job Title:The Senior Upstream Process Engineer, MSAT

Location:Framingham, MA

ABOUT SANOFI:

Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years.  We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees.  Sanofi’s portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine.

Sanofi, an integrated global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients’ needs.  Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes, human vaccines, innovative drugs, consumer healthcare, emerging markets, and animal health.

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products. 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 launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.

Manufacturing, Science & Technology (MSAT) is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. MSAT ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

Summary of role:

  • Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement

  • Anticipate, respond to, and permanently resolve issues that arise during production.

  • Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.

  • Lead the creation and use of digital process data analytic systems.

  • Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Key Responsibilities:

The Senior Upstream Process Engineer, MSAT is expected to:

  • Lead MSAT support to Thyrogen, Fz-ICB, and Falcon upstream commercial operations.

  • Lead a group of experts/engineers that provide technical/scientific support, expertise, and guidance to manufacturing and quality. 

  • Support ongoing development of staff to maximize individual team performance.

  • Utilize a solid understanding of scientific principles and professional practices to solve a range of complex problems in creative and practical ways.

  • Provide input and coordinates support from process development teams. Coordinates with cross functional teams to progress lab studies.

  • Reviews manufacturing processes and/or development and production data.

  • Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.

  • Provide CMC support and guidance for product lifecycle management.

  • Attend development and scientific meetings to remain current with technology and regulatory guidelines. Interact with colleagues from various company functions in particular Engineering, Science, Manufacturing, Quality, and MSAT functions to meet the group’s goals.

Basic Qualifications:

  • Bachelor’s Degree with 9 years of relevant industry experience OR

  • Master’s degree with 7 years of relevant industry experience OR

  • Ph.D. with 5 years of relevant industry experience AND

  • A degree in engineering or science

AND

  • Possess Leadership Qualifications, such as: Build, manage, motivate, and empower teams and workgroups. Take responsibility for developing one’s self and others in anticipation of future business needs.

  • Experience with large scale cell culture or purification manufacturing.

  • Experience leading technical teams and leading projects.

  • Experience communicating with cross functional teams and senior management.

  • Experience providing solutions for difficult technical issues.

Preferred Qualifications:

  • Strong technical writing skills.

  • Experience with high level data analysis.

  • Experience in biotechnology or the pharmaceutical industry.

  • Experience with root cause analysis and/or risk assessment.

  • Experience working with statistical analysis software.

Special Working Conditions:

  • Occasional travel expected.

  • Ability to lift weight.

  • Ability to gown and gain entry to manufacturing areas.

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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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