Director of Analytical Development

Job Summary

To support an innovative biotechnology organization, the fully remote Director of Analytical Development will oversee analytical strategy, manage external partners, and lead cross-functional collaboration to accelerate complex pharmaceutical programs through key development milestones.

Key responsibilities:

• Lead analytical development activities for drug substance and drug product programs, including method development and validation
• Act as the primary analytical and CMC representative on cross-functional project teams, collaborating with various stakeholders
• Manage CROs and contract laboratories to ensure timely execution of analytical development objectives and deliverables

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 including HPLC, dissolution testing, and method development
• Experience managing CROs and influencing cross-functional teams and stakeholders
• Working knowledge of cGMP requirements and FDA, EMA, and ICH regulatory guidelines