Job Title : Scientist 1 MSAT
Location: Framingham, MA
About the Job
The Scientist I will develop and execute bioassays across various biologic modalities in support of commercial manufacturing and continuous improvement initiatives. In addition, this role will support Stability study management and the execution of biochemical and biophysical assays, as needed.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
Main Responsibilities
Execute cell-based assays and immunoassays to assess product potency, biological activity, and impurities (e.g., residual DNA, HCPs) in support of late-stage programs, commercial biologics, and life cycle management programs
Develop and optimize analytical methods including cell-based assays, ELISA, and flow cytometry for MSAT projects and technology transfer activities; perform general biochemical and biophysical assays under SME supervision, as needed
Perform method qualification and transfer in and out of the department
Work with analytical leads and relevant stakeholders to support sample stability studies
Ensure timely completion of assignments and deliverables; independently design and execute complex experiments under general supervision
Participate in characterization and comparability studies
Author protocols, method development/technical reports, data analysis summaries, and investigation reports
Write and review method documentation and characterization reports in support of regulatory filings
Collaborate with other scientists in the team, as well as interact cross-functionally in the Global MSAT organization and interface functions and organizations, such as CMC, Quality, Manufacturing, CMO/CROs as appropriate
About You
Basic qualifications:
PhD with 0–1+ years' experience in the biopharmaceutical industry, OR Master's degree with 3+ years' experience, OR Bachelor's degree with 6+ years' experience in the pharma/biotech industry within analytical development
Scientific background in cell biology, biochemistry, molecular biology, immunology, or a related field
3+ years hands-on experience with cell-based assays, immunoassays (e.g., ELISA), and/or flow cytometry in a laboratory setting
Experience in experimental design, method development, and qualification
Strong analytical and problem-solving skills with the ability to troubleshoot complex assay issues and interpret scientific data
Knowledge of mammalian cell culture and commercial protein purification processes
Experience with bioanalytical equipment, software, and statistical tools for high-level data analysis
Proficiency in data analysis tools and laboratory information management systems .
Skills and Competencies:
Highly organized and detail-oriented with a demonstrated commitment to quality and accuracy
Able to work independently and collaboratively within cross-functional teams and with external partners; enthusiastic, self-motivated, and agile in responding to urgent requests, with the initiative to lead new tasks
Excellent written and oral communication skills with the ability to present complex technical information clearly
Strong time management and ability to prioritize multiple projects
Ability to work full-time onsite in an analytical lab environment
Preferred qualifications:
Experience with method development, method qualification, and/or validation
Knowledge and hands-on experience with sample stability testing and management
Hands-on experience and comprehensive knowledge of other biochemical and…