Senior Manager, Process Chemistry

Senior Manager overseeing active pharmaceutical ingredient manufacturing at contract manufacturing organizations, managing tech transfer, process optimization, and CMC strategy for clinical and commercial products.

Responsibilities

• Oversee API and intermediate manufacturing at CMOs including tech transfer and scale-up operations
• Drive process optimization and validation while ensuring continued manufacturing refinement
• Provide technical expertise and review quality documentation for process improvements
• Support commercial product portfolio with periodic technical assistance
• Collaborate across regulatory, quality, and operations teams on CMC development strategy

Requirements

• PhD in chemistry or chemical engineering, OR Master's degree with 3+ years API manufacturing process development experience
• 2+ years implementing pharmaceutical manufacturing technology improvements in regulated environments
• Experience collaborating with CMO operations and managing manufacturing scale-up activities
• Knowledge of quality systems, validation principles, and statistical process control
• Understanding of CMC drug substance regulatory filings and cGMP requirements
• Strong verbal and written communication with ability to work in multidisciplinary teams
• Background in new chemical entity synthesis or physical organic chemistry preferred

Compensation: $127,000-$165,500 annual