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JOB TITLE: Scientist I
DEPARTMENT: Global Manufacturing Science and Technology
SALARY GRADE: L2-1
REPORTS TO: Analytical Science and Technology
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 Biologics Global Manufacturing Science and 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:
- Work under general direction and may consult with management to obtain information and to build consensus regarding project direction.
- Display strong investigative or technological orientation with independence of experimental design in both cases by performing complex analytical procedures and implementing new techniques.
- May oversee lower level analysts in the execution, design and interpretation of experiments.
- May lead some aspect of a project in a small lab group.
- Design and execute analytical method development and qualification, and method transfer.
- Review data for compliance to procedures and specifications
- Assist in the development, revision and authoring of complex, explicit documentation, i.e. new and current procedures, study protocols, and technical reports.
- Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process; solve assay/analytically-related process problems.
- May participate in coordination of completion of specific project tasks with other departments or other Sanofi functional areas or teams.
- Represent the organization in providing solutions to basic technical issues associated with specific projects.
- Stay current with regulatory guidance for biologics drug development and contribute at a high level to projects related to regulatory commitments.
- Contribute to the scientific literature, external conferences.
- MS degree 5 with years of laboratory experience in analytical/biochemistry research and/or development.
- Trained background in LC-MS (Liquid Chromatography - Mass Spectrometry) protein analysis, hands-on experience in performing peptide mapping and/or protein structure analysis.
- PhD and 0-2 years of laboratory experience in analytical or biochemistry research and/or development.
- Strong computer skills in relevant applications.
- Strong written and verbal communication skills.
SPECIAL WORKING CONDITIONS: N/A
- Working in a lab.
- Ability to lift 20 lbs.
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.
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.
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