Associate Director, Analytical Development

📋 Description

• Lead analytical development strategy for drug substances and inhalation products, including method
• Drive late-stage inhalation characterization of critical quality attributes (e.g., delivered dose
• Develop product control strategies linking analytical methods, specifications, stability, in-use
• Support comparability and bridging activities during changes to processes, formulations, devices
• Lead analytical validation and transfer activities with protocol/report development and oversight
• Provide analytical leadership for PPQ and commercial readiness, including regulatory submissions

🎯 Requirements

• Advanced scientific education, Ph.D. or equivalent in Analytical Chemistry, Pharmaceutical
• 8+ years of analytical development experience in biotech/pharma, with inhalation product exposure
• Strong late-stage and cGMP experience across clinical development, PPQ, and commercialization
• Demonstrated expertise in analytical method development, validation, and transfer, including
• Inhalation drug development experience desirable (devices, aerosol characterization, performance
• Regulatory and CMC experience with FDA/EMA expectations and inspections; external partner

🎁 Benefits

• Competitive base salary: approximately $180,000–$205,000 USD annually.
• Remote work within the United States.
• Opportunity to influence late-stage development and commercialization of inhaled therapies.
• Significant ownership across analytical development, regulatory readiness, PPQ, and manufacturing
• Collaborative environment with internal teams and external CDMO partners.
• Growth through exposure to advanced inhalation tech, regulatory activities, and cross-functional