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Process Engineer IV

Framingham, Massachusetts



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Job Overview

The Process Engineer works in the Global Manufacturing Science and Technology department as a technical leader providing downstream process support to commercial drug substance production at the Framingham MA Biologics site.


  • Recommend strategies for improving purification process performance for GMP operations in a multi-product plant. Establish continuous improvement strategies and lead the proposal, initiation, testing, and implementation of changes to purification processes

  • Provide a science-based approach and advise members of project teams for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies

  • Lead or participate in Process Validation and Technology Transfer to internal or external manufacturing facilities, as well as HA (heath authority) prior approval inspection for commercial license and product launch

  • Support HA audits and provide responses to regulatory questions

  • Serve as site representative on cross functional teams including Sanofi Genzyme global network teams, technology transfer teams, and CMC project teams

  • Network with Manufacturing, Quality, and Regulatory organizations to establish a reliable state of process control

  • Author and/or review documents (technical memos, protocols, reports, etc.) related to process monitoring programs, at-scale or scale-down studies, annual product reviews, and non-conformances

  • Maintain full working knowledge of principles and theories, and advance our understanding and control in both current and the 2nd gen commercial processes

  • Keep abreast of industrial best practices, and evaluate their potential application across multiple programs within the organization when needed

Requirements & Qualifications:

Basic Qualifications:

  • PhD in a scientific discipline (Cell or Molecular Biology, Biochemistry, Chemical Engineering, Biochemical Engineering, or related field) with 3+ years relevant experience in cGMP manufacturing environment or biologics process development, or MS with at least 6+ years, or BS with 8+ years of experience.

  • Experience in mammalian cell culture purification techniques with in-depth understanding of large-scale chromatography and UF/DF unit operations, principles of biochemical engineering, and process data analysis

  • Demonstrated ability to lead technical projects and small teams

  • Full understanding of compliance and cGMP considerations

  • Demonstrated commitment to continuous improvement – at the individual, department and organizational level

Preferred Qualifications:

  • Ability to make a significant contribution to cross-functional project teams through technical expertise and scientific creativity

  • Extensive experience in the process development, technical transfer, process characterization, and operation of large-scale protein purification processes

  • Direct audit support experience

  • Ability to work effectively in a highly collaborative and dynamic environment, and mentor/teach junior team members

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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