Senior Scientist, MSAT

Role Summary

Senior Scientist, MSAT – Location: Framingham, MA

The Senior Scientist will be responsible for developing and executing bioassays for various biologic modalities while 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

Preferred Qualifications

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

Skills

• Highly organized and detail-oriented
• Demonstrated ability to work independently and collaboratively
• Strong written and oral communication skills; excellent presentation abilities
• Proven ability to work in a matrix and highly technical environment
• Flexibility to adjust to a fast-paced, goal-oriented environment
• Willingness to expand and broaden skillset