Scientist II

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 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 The 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: Position Summary This position is primarily responsible for authoring and directing analytical method lifecycle management studies within the Biologics network. Key Responsibilities Develop a strategy for analytical method development, method qualification/validation, method transfer, and method comparability studies (internally or externally) Develop and author complex, explicit documentation, i.e. new procedures, study protocols, and technical reports incorporating appropriate use of statistics Provide oversight to execution of protocols Review data for compliance with procedures and specifications Perform investigations of laboratory events and protocol deviations and discrepancies Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process; solve assay/analytically related process problems Collaborate with group members and cross-functional teams to support specific projects Manage project workloads to achieve shared goals and meet timelines Author analytical method sections of regulatory dossiers Work independently without supervision May oversee lower-level analysts in the execution, design, and interpretation of experiments Adhere to Sanofi GMP and safety procedures and guidelines BASIC QUALIFICATIONS Ph.D. in Analytical Chemistry, Biochemistry, or a related discipline with 0-2 years of industry experience, a master''s degree with a minimum of 4+ years of industry experience, or a bachelor''s degree with 6+ years of industry experience in relevant fields Experience in executing and directing studies for Analytical Method Development, Validation, and Transfer Scientific technical writing ability including authoring and revising SOPs, validation protocols, and technical reports Knowledge of USP and global compendial regulations and requirements for method life cycle activities Effective oral and written communication skills (English Language) Ability to work well both independently and in a team environment PREFERRED QUALIFICATIONS: Experience in performing and validating bioassays (activity, cell-based bioassays, ELISA) Experience in leading technical projects Proficient in MS Outlook, Word, and Excel Effective presentation skills in presenting technical data Knowledgeable in basic statistical applications including statistics for analytical methodsa SPECIAL WORKING CONDITIONS: Occasional laboratory work with minimal use of chemicals. Ability to lift 20 lbs. 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. 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 PDN 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. This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2026-04-04