Associate Director, Drug Product

📋 Description

• Lead drug product formulation and process development for inhaled dry powder products, including
• Apply Quality by Design (QbD) principles to identify Critical Quality Attributes (CQAs) and
• Compile, analyze, and trend drug product performance data and stability results using statistical
• Oversee technical deliverables from external manufacturing partners and review key documentation
• Support commercial manufacturing readiness, including planning and executing Process Performance
• Provide scientific and technical oversight of drug product and inhaler compatibility, container

🎯 Requirements

• Bachelor's, master's, or doctoral degree in Pharmaceutical Sciences, Pharmaceutics, Chemical
• At least 10 years of drug product development experience, including substantial expertise in
• Demonstrated experience managing external CDMO relationships and owning technical deliverables for
• Hands-on expertise in inhalation formulation development, manufacturing process scale-up
• Working knowledge of current Good Manufacturing Practice (cGMP), International Council for
• Experience with CMC Module 3 documentation and preparation of New Drug Applications (NDAs) or

🎁 Benefits

• Opportunity to contribute to the development of innovative inhaled therapies for serious pulmonary
• A technical leadership role with influence across formulation development, manufacturing readiness
• Cross-functional collaboration with specialists in drug substance, analytical development, clinical
• Exposure to late-stage clinical development, external manufacturing partnerships, process
• Opportunity to help shape development strategies and resolve complex technical challenges within a