Process Engineer Senior
The Senior Process Scientist / 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 4+ 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
Terms of employment
The Sr. Process Scientist/Engineer is an individual contributor role with no direct reporting responsibilities but the ideal candidate must be able to lead project teams independently and work in a matrix management environment. Standard business hours apply and routine travel is not expected.
What makes this position unique?
Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved. Benefits of working in this role:
- Cross-functional team leadership provides visibility and exposure to multiple areas in the organization.
- Sanofi is building a state of the art biologics manufacturing network based on continuous manufacturing and heavily leveraging disposables. The ideal candidate will have the opportunity to support multiple manufacturing processes in Framingham and other locations in North America.
- Sanofi actively encourages internal career development growth opportunities. This senior position enables potential future advancement as a people manager or senior-level individual contributor in technical roles.
This position will be based on Framingham. Occasional visits to other Massachusetts locations may be required.
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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