Senior Director of Analytical Sciences

Job Summary

To support a growing pharmaceutical company, the full-time Senior Director of Analytical Sciences will provide analytical strategy and oversight for pharmaceutical products, including vendor management, regulatory submissions, and analytical method development, in a remote work environment.

Key responsibilities

• Develop and execute the analytical strategy for the CMC Department, ensuring alignment with company objectives
• Prepare analytical sections of regulatory submissions and interact with international regulatory agencies on CMC analytical topics
• Act as Subject Matter Expert to support decisions and drive improvements across clinical, regulatory, and product development functions

Required qualifications

• PhD in Analytical Chemistry or a related field with at least 15 years of experience in Analytical Sciences within the pharmaceutical or medical device industries
• Extensive knowledge of drug product analysis, including method development, validation, and transfer
• Demonstrated experience managing teams with diverse analytical backgrounds
• Strong understanding of relevant regulations and the regulatory process
• Commitment to the company's vision, mission, core values, and culture