Staff Scientist, Biologics

Job Summary

To support the development of complex biologics, the remote Staff Scientist, Biologics will serve as the in-house expert for analytical method development and characterization, author regulatory CMC sections, and manage projects with external contract organizations.

Key responsibilities

• Design, execute, and interpret analytical methods for biologics, leading characterization studies using advanced mass spectrometry and structural techniques
• Author and review regulatory CMC sections for IND/BLA submissions, including technical reports and protocols
• Plan project scope, lead tech transfers, and act as the primary technical contact to ensure project timelines and deliverables are met

Required qualifications

• PhD in a scientific or engineering discipline, with a minimum of 10 years of biotechnology or pharmaceutical industry experience focused on biologics analytical development
• Proven mastery of analytical method development for complex proteins, including hands-on experience with mass spectrometry
• Strong knowledge of rational formulation design, protein stability, and FDA/cGMP/cGLP regulatory requirements
• Exceptional written and verbal communication skills, capable of translating complex scientific data for diverse audiences
• Excellent organizational and time-management skills, with a proven ability to manage multiple concurrent programs