This position within the Manufacturing Sciences, Analytics, and Technology (MSAT), performs activities supporting the development, validation and continuous improvement of filling 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:

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

• Serve as a technical expert for general projects, transfers, and change management implementation with emphasis on syringe and vial filling.

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

Accountabilities:

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

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

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

• Lead/support troubleshooting activities

The Job Responsibilities Include:

• A technical contributor to filling

• Influences internally and is forward thinking with an attitude of collaboration, optimization, efficiency, and continuous improvement

• 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 filling processes for vaccines and bio-pharmaceuticals

• Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions, and actions for resolution

• Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate

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

BASIC QUALIFICATIONS:

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

• 3 years of filling and/or manufacturing experience or an Associate degree

• Able to do project-driven shift support (10% of the time)

PREFERRED SKILLS:

• Strong technical writing skills

• Attitude of collaboration

• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

OTHER SKILLS:

• Strong communication skills, self-motivated

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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