Senior Principal Scientist

Job Summary

A company is looking for a Senior Principal Scientist, Technical Operations.

Key Responsibilities

• Lead the end-to-end drug product development strategy, including formulation and clinical manufacturing
• Act as the technical lead for drug product activities with CDMOs, overseeing selection and troubleshooting
• Author and review drug product CMC sections for regulatory submissions and represent CMC in regulatory interactions

Required Qualifications

• Ph.D. in Material Science, Chemical Engineering, or related physical science
• 10+ years of industry experience in drug product strategy through clinical stage development
• Proven experience leading development of novel molecular entities
• Significant experience managing CDMOs for formulation development and GMP manufacturing
• Demonstrated ability to operate effectively in a dynamic startup environment