Director of Analytical Development

Job Summary

Leading analytical development initiatives, the fully remote Director of Analytical Development will oversee drug substance and product programs, manage external partnerships, and guide cross-functional collaboration to accelerate pharmaceutical development milestones.

Key responsibilities:

• Lead analytical development activities, including method development, validation, and technology transfer
• Act as the primary analytical and CMC representative on cross-functional project teams
• Manage CROs and contract laboratories to ensure timely execution of analytical development objectives

Required qualifications:

• MS degree in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related scientific discipline
• 7+ years of experience in pharmaceutical, biotechnology, or contract research with expertise in analytical development and CMC activities
• Strong knowledge of analytical techniques such as HPLC and method development
• Experience managing CROs and influencing cross-functional teams
• Working knowledge of cGMP requirements and FDA, EMA, and ICH regulatory guidelines