Description

You will drive progress of early and late-stage molecules by delivering phase-appropriate analytical methods, validation, and tech transfers. Partnering cross-functionally, you'll support process development, formulations, CMC, and quality activities to advance our breast cancer pipeline.

Requirements

• MS or PhD in Chemistry or equivalent scientific discipline
• Expertise in analytical development and quality control for both drug substances and drug product
• Knowledge of cGMP, ICH, and FDA regulations/guidance
• 7+ years relevant industry experience in small molecule analytical development, including late-stage clinical development and preparation for product registration
• Experience partnering with cross-functional teams and providing analytical development leadership

Responsibilities

• Support analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
• Conduct analytical technical review of method validation/qualification protocols, data, and reports generated at CDMOs
• Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing
• Work on stability programs, monitor/trend stability data, establish retest periods or shelf lives
• Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations