Principal Scientist
Sanofi - Framingham, MA
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Analytical Science and Technology (AST) is a function of the Sanofi Biologics Global Manufacturing Science & Technology (MSAT) organization. The AST function is specifically responsible for supporting commercial manufacturing of biologic drug substance (DS) and is responsible for method and platform technology development for analytical life cycle management (LCM) and support of process development for LCM. Support commercial biologics and analytical LCM Support 2nd generation process development for biologics DS Partner with internal and external functions to transfer and implement novel analytical methods and technology Support regulatory filings CORE RESPONSIBILITIES Work independently. Establish and define technical objectives of programs and directs the execution of efforts to meet objectives. Exercise considerable latitude in determining technical objectives and approaches to assignment. Plan, direct, and execute laboratory development activities by assessing underlying technical and conceptual risks and defining approaches and methodologies which are innovative and creative in order to achieve goals Initiate projects that have risks such as the development of novel technologies or the application of individual expertise to new areas. Maintain broad knowledge of the state of the art principles and theory. Stay current with regulatory guidance for biologics products and make a significant contribution in dealing with regulatory commitments and responses. Take leadership role contributing to scientific literature and conferences and builds respect within the company as reflected by these contributions. Develop and author complex, explicit documentation for new and current procedures, protocols, and technical reports. Design and execute analytical method development and method transfer. Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process. Contribute to the understanding and interpretation of results and how they impact the design of subsequent experiments. Guide the successful completion of major projects and may function in a project leadership role. Develop project strategy in consultation. Represent the organization in providing solutions to difficult technical issues associated with specific projects. Independently employ in-depth technical knowledge to define and manage laboratory studies. Manage and direct the work of analysts and scientists. Interact with external personnel on significant technical matters often requiring coordination between organizations. BASIC QUALIFICATIONS: Bachelor''s degree or Master''s degree or equivalent and 10+ years of experience. Ph.D. or equivalent and 8+ years of experience. Technical expert in two or more platforms. Strong written and verbal communication skills. Supervisory experience. PREFERRED QUALIFICATIONS: Excellent organizational skills. Project management skills. Working knowledge of GLP Knowledge of biologics development Awareness of ICH and other regulatory guidelines As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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. GD-SG LI-GZ 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.
Created: 2025-11-15