Senior Scientist II

Senior Scientist II in Process Chemistry at Exelixis supports small-molecule drug development from early stages through commercialization. The role involves executing process development internally and collaborating with contract manufacturers on scale-up, technology transfer, and regulatory compliance for drug substances.

Responsibilities

• Evaluate synthetic routes and develop scalable processes for small-molecule drug substances and intermediates
• Characterize process impurities and establish control strategies aligned with development phase requirements
• Prepare technical packages for process transfer and serve as technical expert supporting CDMO manufacturing
• Author regulatory submissions including sections of NDAs, MMAs, and INDs as required
• Collaborate with cross-functional teams and CDMOs to ensure compliant, on-time drug substance production

Requirements

• Bachelor's degree in organic chemistry, chemical engineering, or pharmaceutical science with 9+ years industry experience
• Master's degree in related field with 7+ years pharmaceutical or biotech experience
• PhD in organic chemistry, chemical engineering, or related field with 2+ years industry experience
• Knowledge of process chemistry, synthetic organic chemistry, and analytical methods (NMR, MS, HPLC)
• Experience with contract manufacturing organizations across North America, EU, and Asia preferred
• Strong written and verbal communication skills with ability to work independently and cross-functionally
• Detail-oriented and self-motivated with excellent organizational skills; up to 10% domestic travel

Compensation: $132,500-$188,000 base annually