Scientist 1 MSAT

Sanofi • Framingham, MA

2d • $85,500 - $123,500 • Onsite

About The Position

The Scientist I will develop and execute bioassays across various biologic modalities in support of commercial manufacturing and continuous improvement initiatives. The role also supports stability study management and, as needed, the execution of biochemical and biophysical assays. The position is part of Sanofi’s Manufacturing & Supply organization and is based onsite in an analytical laboratory in Framingham, Massachusetts.

Requirements

• PhD with 0–1+ years of biopharmaceutical industry experience, or a master’s degree with 3+ years of experience, or a bachelor’s degree with 6+ years of pharma/biotech industry experience within analytical development.
• Scientific background in cell biology, biochemistry, molecular biology, immunology, or a related field.
• At least 3 years of hands-on laboratory experience with cell-based assays, immunoassays such as ELISA, and/or flow cytometry.
• Experience in experimental design, method development, and qualification.
• Strong analytical and problem-solving skills, including 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 with data analysis tools and laboratory information management systems.
• Highly organized and detail-oriented, with a demonstrated commitment to quality and accuracy.
• Ability to work independently and collaboratively within cross-functional teams and with external partners; self-motivation, agility in responding to urgent requests, and initiative to lead new tasks.
• Excellent written and oral communication skills, including 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 laboratory environment.

Nice To Haves

• 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 biophysical techniques, including U/HPLC, CGE, cIEF, spectroscopy, and particle analysis.
• Familiarity with biologics manufacturing, including monoclonal antibodies, vaccines, or other biotherapeutics.
• Experience working on highly technical projects requiring adaptability and responsiveness.

Responsibilities

• Execute cell-based assays and immunoassays to assess product potency, biological activity, and impurities, including residual DNA and host cell proteins, for 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 methods into and out of the department.
• Work with analytical leads and relevant stakeholders to support sample stability studies.
• Complete assignments and deliverables on time and independently design and execute complex experiments under general supervision.
• Participate in characterization and comparability studies.
• Author protocols, method development and technical reports, data analysis summaries, and investigation reports.
• Write and review method documentation and characterization reports in support of regulatory filings.
• Collaborate with scientists on the team and work cross-functionally within Global MSAT, including with CMC, Quality, Manufacturing, and CMO/CRO partners as appropriate.

Benefits

• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs; additional benefits information is available through the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level