Senior Scientist, MSAT

Role Summary

Senior Scientist, MSAT at Framingham, MA. Develops and executes bioassays for various biologic modalities, collaborating cross-functionally within the Global MSAT organization and interfacing with Development/CMC, Quality, Manufacturing, and external partners.

Responsibilities

• Develop and execute bioassays, binding and immunoassays for various biologic modalities, including mAbs, ADCs, multi-specific antibodies, enzymes and recombinant proteins, and other biologic modalities
• Lead and perform method qualification and transfers in/out of the department
• Develop and implement technology platforms, including novel techniques and technologies
• Create and execute study plans independently and with guidance from the direct manager and other SMEs
• Collaborate cross-functionally within Global MSAT and interface with Development/CMC, Quality, Manufacturing, and CMO/CROs
• Serve as representative on cross functional teams including Sanofi network teams, technology transfer teams, and project teams
• Lead and perform characterization and comparability studies
• Author protocols, technical reports, data analyses, process investigations, and procedures
• Contribute to control strategy establishment in bioassays, immunoassays, and binding assays
• Support regulatory filings as needed
• May supervise associates or junior scientists

Qualifications

• PhD with 5+ years' experience OR Master‚Äôs degree with 7+ years' experience OR Bachelor‚Äôs degree with 9+ years' experience
• Experience in Biopharmaceutical Industry
• Degree preferably in Cell Biology, Biochemistry, Molecular Biology, immunology or similar field
• 5+ years‚Äô experience with bioassays and immunoassays
• Knowledge of mammalian cell culture and commercial protein purification processes
• Experience with bioanalytical equipment and software
• Experience in analytical method development/troubleshooting
• Supervisory experience (managing and developing staff)
• Project management skills

Skills

• In-depth understanding of regulatory requirements for CMC analytical development (preferred)
• Expertise in flow cytometry and bioassay/immunoassay development (preferred)
• Strong statistical knowledge and demonstrated practical applications (preferred)
• Experience with novel biologic modalities (gene/cell therapies, RNA based therapeutics) (preferred)
• Demonstrated potential to serve as a bioassay/immunoassay SME (preferred)
• Track record of scientific publications in bioassays and immunoassays (preferred)

Education

• Not specified beyond degrees listed in qualifications

Additional Requirements

• None specified