Manager Scientist MSAT - Vaccine

Job description

ABOUT THE ROLE:

This position of Manufacturing and Supply Process Engineer I Scientist, within the Manufacturing Sciences, Analytics, and Technology (MSAT) function of Industrial Affairs, performs activities supporting the development, validation and continuous improvement of visual inspection processes for Drug Products.  The mission of the MSAT function is to deliver robust and efficient processes & testing with associated knowledge to transfer to Manufacturing & QC. The MSAT function also provides daily support to manufacturing and QC toward industrial performance excellence.  The individual in this position will:

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Drive the technical strategy and project deliverables across the Injectables (Drug Product) landscape for multiple projects across the Swiftwater site

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Serve as a technical expert for general projects, transfers, and change management implementation with emphasis on Visual Inspection

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Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines

ACCOUNTABILITIES:

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Support and deliver technical studies and validation strategies for Manufacturing Assistance, Technology Transfers, and New Vaccines visual inspection operations

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Provide Shop Floor assistance to support investigations, troubleshooting, CAPA, and Change Control activities

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Author I review I approve technical documents which support project execution and manufacturing assistance

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Participate, support, defend, and provide technical expertise during Pre-Approval Inspections and agency inspections when required to defend studies

The Job Responsibilities Include:

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Having a strong working knowledge of defect set creation and the relationship between visual inspection parameters, vaccine product characteristics and critical quality attributes.

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Working with different disciplines (Quality, Operations, Regulatory, and Engineering) in the execution of development and validation studies to industrialize processes for Phase 3 and licensed products to assure commercialization of robust, compliant, and efficient processes for vaccines and bio-pharmaceuticals

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Participating in programs that use structured methodologies such as Quality by Design, Design Space and Process Control Strategies in the course of industrial process design, validation and control.

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Providing technical coaching, training and guidance to junior engineers on visual inspection related subject matter

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Leading tactical responses to process deviations, delivering technical solutions and communicating outcomes to site management

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Promote innovation to keep up-to-date with the latest regulatory expectations and industry trends.

BASIC QUALIFICATIONS:

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Bachelor in Basic Sciences, Pharmacy, Chemical Engineering or Mechanical Engineering

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2-5 years of experience with drug product visual inspection development and validation

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Knowledge of the design, operation and peripheral processes associated with automated inspection machines or defect sets

PREFERRED SKILLS:

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Strong technical writing skills

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Attitude of collaboration

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Ability to coach junior staff members

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eDoc, SAP, Phenix proficiency

OTHER SKILLS:

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Strong communication skills, self-motivated

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Proficiency in Word, Excel, PowerPoint

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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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.