Associate Director of Analytical Development

Job Summary

Leading analytical strategy for late-stage drug substance and inhalation product development, the full-time Associate Director of Analytical Development will provide technical leadership for method development, validation, and lifecycle management while collaborating with cross-functional teams and external partners in a remote capacity.

Key Responsibilities:

• Lead the development, optimization, and validation of analytical methods for drug substances and inhalation products
• Design and oversee late-stage characterization of inhalation product quality attributes and develop control strategies
• Author and review analytical sections of regulatory submissions and support Health Authority inspections

Required Qualifications:

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field; Master's degree with significant experience will also be considered
• 8+ years of analytical development experience in the biotech/pharma industry, particularly with inhalation products
• Strong experience with cGMP late-stage development and commercial manufacturing
• Proven ability to oversee external CDMOs and contract laboratories
• Expertise in developing regulatory and CMC documentation, with experience in FDA and EMA inspections preferred