Senior Scientist, Drug Formulation

Job Summary

A company is looking for a Senior Scientist, Drug Product Formulation.

Key Responsibilities

• Lead drug product formulation development and manufacturing from conception through commercialization
• Partner with pharmaceutical development to define drug product quality attributes and control strategies
• Manage relationships with CDMOs to ensure timely delivery of analytical data for pharmaceutical development and clinical trials

Required Qualifications

• Bachelor of Science degree in Chemistry or relevant discipline with a minimum of 5 years of pharmaceutical industry experience
• Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements
• Subject matter expert in solid oral formulations and manufacturing processes
• Proven track record in delivering Pharmaceutical Development milestones on-time
• Experience with US and EU regulatory filings at both clinical trial and marketing application stages