Process Engineer IV
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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:
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
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.
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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