Director, Analytical Development and Quality Control

Job description

The Opportunity We are seeking a highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you will establish and lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions. You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions. This is a highly visible leadership role with responsibility for shaping analytical strategies that enable the successful advancement of our clinical pipeline. Your Role: - You will be responsible for setting and executing the analytical development and quality control strategy across our development programs, ensuring phase-appropriate analytical methods and control strategies are in place to support drug substance (DS) and drug product (DP) development. - You will lead analytical method development, validation, and lifecycle management activities required f...