Associate Director CMC Quality

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination products.
At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.

We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.

Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries

The Associate Director, CMC Quality Assurance is a senior Quality leader accountable for providing strategic and hands‑on GMP quality oversight across Aerogen Pharma's development programs. The position serves as the primary Quality partner to CMC, Device, Supply Chain, Regulatory Affairs, Clinical Supply, Program Leadership, and external manufacturing and testing partners, ensuring that development activities are executed with appropriate quality rigor, regulatory compliance, and phase‑appropriate systems while preserving the speed and pragmatism required in an entrepreneurial pharmaceutical company.
Reporting to the VP of Quality Assurance, the Director CMC Quality Assurance role requires a leader who can move seamlessly between strategic Quality decision‑making and detailed execution: establishing GMP quality strategy, challenging technical and compliance assumptions, making risk-based decisions, resolving issues in real time, and personally driving critical work when resources are constrained or timelines are compressed.

• Own and execute the CMC Quality strategy across development programs, ensuring phase‑appropriate GMP controls, decision frameworks, and readiness for registration and commercialization.
• Serve as the senior Quality partner to CMC, Device, Regulatory Affairs, Clinical Supply, Supply Chain, Program Leadership, and external partners, providing independent, risk‑based Quality judgment.
• Provide GMP oversight for drug substance, drug product, device and drug‑device combination interfaces, analytical testing, stability, packaging, labeling, clinical supply, and related CMC operations.
• Ensure effective governance and execution of core Quality Systems, including deviations, investigations, CAPA, change control, risk management, validation and qualification, documentation practices, training, and applicable complaint processes.
• Lead Quality oversight of CDMOs, contract laboratories, suppliers, and other external CMC partners, including quality…