DEPARTMENT DESCRIPTION:

The MSAT function within Specialty Care Operations (SCO) is responsible for leading technology transfer, implementing control strategy, providing technical process and analytical support, and driving process and analytical lifecycle management (LCM) for biologics drug substance operations. Analytical Science and Technology (AST) is a function of the Sanofi Global Manufacturing Science and Analytical Technology organization. AST is a partner of Process Sciences within MSAT, Biologics Quality, and Manufacturing Departments.

AST provides support to

• 2nd generation process development for biologics DS

• Commercial product and analytical LCM

• Implementation of digital tools and infrastructure

• Advancement of analytical automation, high throughput capabilities, and PAT

• Partner with internal and external functions for technology transfer

• Develop analytical control strategy and support regulatory filings

POSITION OVERVIEW/KEY RESPONSIBILITIES:

Key Responsibilities

• Lead analytical method development activities

• Lead technical transfers of analytical and characterization methods

• Provide analytical testing support and serve as analytical subject matter expert to Process Science, R&D and other groups

• Support second generation projects, process improvement, investigations, Degradation Pathway, Comparability and Technical Transfer studies

• Author protocols, technical memos and reports, data analysis summaries, process investigations and procedures

• Lead initiatives for new analytical techniques and technologies

• Serve as representative on cross functional teams including Sanofi network teams, technology transfer teams and project teams

• Interact cross-functionally with colleagues from various Sanofi Genzyme functions including QCTS, QC, gMSAT to implement best practices

BASIC QUALIFICATIONS

• BS in related discipline with at least 6 years of industrial experiences in relevant fields.

• MS in related discipline with at least 4 years of industrial experiences in relevant fields.

• Ph.D. in related discipline with limited to no industrial experiences in relevant fields.

PREFERRED QUALIFICATIONS:

• Experience with method development for recombinant proteins

• Knowledge of mammalian cell culture and commercial protein purification processes

• Experience with Empower analytical control software

• Experience with statistical tools and high-level data analysis

• Ability to design experiments and troubleshoot problems

• Excellent communication and writing skills

• Ability to work effectively in a highly collaborative and dynamic environment

SPECIAL WORKING CONDITIONS:

• Ability to work in a laboratory environment

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.