Sanofi Group Director, Process Data Analytics, Westborough, MA in Westborough, Massachusetts
Manufacturing Science is part of the Global Manufacturing Science & Technology (Global MSAT) organization. The Global MSAT function within Specialty Care Operations (SCO) is responsible for leading technology transfer, implementing control stratgy, providing technical process support and driving process lifecycle management for biologics drug substance operations. The Process Data Analytics Director reports directly to the Head of Manufacturing Science and is based in Westborough, MA.
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.
• Provide co-located 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.
Manufacturing Science is a function of Sanofi Biologics Global Manufacturing Science and Technology organization.
This is an exciting time for the field of process data analytics. Sanofi has placed a clear focus on advancing our digital capabilities. In the Biologics Platform, the vision for the factory of the future includes paperless manufacturing floors and sophisticated data monitoring that may generate up to 3 billion data points from over 5000 parameters for every single batch. Process data analytics allows us to increase the visibility of process data so that we can better monitor and actively control our processes, build process knowledge, and forecast and improve process knowledge. MSAT uses Process Data analytics to maximize the amount of data involved in decision making by minimizing data loss across both physical and organizational barriers.
The Program Director of Process Data Analytics will be the custodian of the Process Data Analytics roadmap – responsible for facilitating the successful execution, tracking and reporting of its components. Specific responsibilities include:
• Set priorities with input from key stakeholders, users and SMEs to create and refresh the PDA roadmap annually or as needed.
• Develop and maintain a governance system for the oversight of PDA activities.
• Maintain the approved plan of record for the Process Data Analytics Roadmap.
• Partner with IT to align on priorities, secure IT resources, support and expertise as required.
• Partner with SMEs to ensure the successful execution of the components of the PDA roadmap.
• Network with data analytics leads across Sanofi.
• Liaise with data analytics leads at Sanofi alliance companies and CMOs as appropriate.
• Develop tracking and reporting tools to communicate the status of program.
• Actively maintain knowledge of industry best practices related to Process Data Analytics.
• Develop and maintain relationships with a wide array of industry participants; represent Sanofi MSAT PDA externally at industry conferences.
• Propose, secure, maintain and track the PDA Program budget.
• Provide phase documents to Biologics PMO as appropriate for advancement of programs.
• Develop the five-year strategic plan for PDA.
• Employ Project Management, Change Management and/or Sanofi Manufacturing Systems standards and tools as appropriate.
• Ensuring compliance with all legal and business requirements and Sanofi policies and practices.
• Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility as well as talent attraction and talent exchange with other sites.
• Motivating, retaining and developing key employees. Building and sustaining employee engagement by creating an environment within which individuals and teams can excel
BS with 15 years of experience, MS with 12 years, or a PhD with 10 years of experience
Prefer experience in Biotech/Pharma, but a highly qualified candidate with PDA expertise will be considered.
Prefer Chemical engineer or related field, but a candidate with demonstrated ability to navigate and influence in a highly technical environment will be considered.
Strong subject matter expertise or demonstrated ability to lead outside of primary area of expertise.
Demonstrated ability to lead programs and/or projects
Demonstrated ability to influence
Strong communication skills.
Recognized Thought leader in the field of Process Data Analytics with Vision.
Strongly networked in process data analytics space.
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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