Deputy Director Process Engineering, Downstream

Summary:

This position of Drug Substance Process Engineer, Downstream in the Manufacturing Technology (MTech) function of Industrial Affairs, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the Sanofi Pasteur industrial sites. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). Mtechunction also provides daily support for manufacturing and QC toward industrial performance excellence.

Swiftwater IA conducts and optimizes activities in area of specialization with high technical and scientific complexity. Through having a high level of expertise and understanding of the design, control and operation of process unit operations typical of biopharmaceutical and vaccine manufacturing, the individual in this position will work with a cross-functional team from various functions in IA to: develop the process design basis (including mass balance, sizing and selection of equipment and instrumentation for control of robust processes), creation of key deliverables such as URS, and provide input to industrialization strategies and rationale for critical process parameters. This role will also serve as Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.

Accountabilities:

• Responsible for process design and continuous improvements
• Support execution and documentation of development and/or validation studies as well as lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs within area of expertise.
• Document and interpret study results with recommendations
• Provide technical leadership as a subject matter expert in area of responsibility within site or global network
• Assist or lead the development and execution of training programs for appropriate audiences
• Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
• Provide leadership, including project team leadership, within area of expertise

The Job Responsibilities Include:

• Execute life-cycle design and industrialization of downstream drug substance (DS) processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
• Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
• Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents; provide review and input to C&Q strategy and participating in testing of equipment.
• As a subject matter expert (SME), provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).

Basic Qualifications:

• BS in Chemical or Biochemical Engineering with a minimum of 10 years industrial experience or Master's degree in sciences with 15+ years large scale process equipment design, scale-up implementation & validation experience.
• Experience in equipment start-up, qualification and validation is required.

Preferred Qualifications:

• Expertise in one or more downstream process unit operation design typically used in biotech / vaccine manufacturing (chromatography, filtration, inactivation) as well as project / engineering lifecycle;
• Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
• Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
• Knowledge of computer software common to mission (AutoCAD). Expertise in modeling and simulation of biotech manufacturing unit operations and processes is desired (SuperPro Designer, Schedule Pro, CFD).

Sanofi Pasteur SA 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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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