Associate Director, Product Development

About Aerogen Pharma Aerogen Pharma is a US based clinical‑stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high‑performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low‑cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver. What is the role? The Associate Director of Product Development is a critical role in Aerogen Pharma that will be responsible for key aspects of pharmaceutical development of AeroFact (biologic surfactant) or Synthsurf (Synthetic surfactant). The role will focus on phase appropriate product development of surfactant lyophilized formulations, manufacturing process optimization and scale up, and product characterization supporting pre‑clinical and clinical studies. This position will play a central role in establishing and operating Aerogen Pharma’s in‑house development laboratory. The Associate Director will lead hands‑on formulation and process development of lipid/peptide formulations, including design, execution, and iteration of experiments. The role requires expertise with lipid‑based formulations, lyophilization, protocol development, and cross‑functional experimental execution in collaboration with process engineers, analytical scientists, and lab technicians. Once formulations are developed, the Associate Director will conduct product understanding and characterization studies and lead scale‑up and technology transfer to CDMOs. What are the key responsibilities? Leadership & Strategy: Oversee product development for biologics, proteins, and peptides, managing projects with CDMOs. Develop and execute strategies aligned with Aerogen Pharma’s mission and regulatory standards. In‑House Laboratory Development: Establish and manage a formulation/process development laboratory. Design and execute protocols, perform hands‑on formulation and process development, including homogenization and lyophilization of lipid/peptide formulations, and coordinate iterative experimental work with a cross‑functional team. Product Development: Research, design, and execute controlled experiments, with high attention to detail to develop stable and effective drug products fit for commercialization. Conduct QbD experiments to identify CQAs that impact product performance and stability. Conduct registration‑enabling stability studies and product characterization studies per appropriate ICH guidances. Product Understanding & Characterization: Lead detailed product characterization studies once lead formulations are developed, ensuring comprehensive product knowledge prior to scale‑up. CDMO/CMO Collaboration: Serve as the primary liaison with external manufacturing and analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations. Scale‑Up & Tech Transfer: Translate laboratory‑developed formulations into scalable processes, overseeing transfer to CDMO partners. Regulatory Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements. Experience authoring late‑stage regulatory dossiers, particularly BLAs, is required. Cross‑Functional Collaboration: Work closely with R&D, Manufacturing, Regulatory, and Quality Assurance teams to integrate product development within overall project goals. Troubleshooting & Problem Solving: Address and resolve formulation, process optimization, and analytical issues during development and manufacturing. Implement corrective and preventive actions as needed. What education and experience are required? Ph.D. in Pharmaceutical sciences, Chemical engineering, Biochemical engineering or related field. 8–10 years in lipid formulations, liposomes, or related drug delivery technologies. Hands‑on experience in formulation and process development, including homogenization and lyophilization. 2–5 years of manufacturing process development (lyophilization) is a plus. Extensive experience working with CDMOs is required. Late‑stage product development experience is required. Experience authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a must. Knowledge and experience in drug‑device development, inhalation drug delivery is a plus. Knowledge of Good Manufacturing Practices, ICH, FDA, Health Canada, and MHRA Regulations is required. Excellent written and oral communication skills. What key skills will make you great at the role? Technical Expertise: Strong hands‑on formulation and process development skills, including homogenization and lyophilization. Experience with lipid‑based products (including peptides / proteins) is required. Experience with lyophilization manufacturing process development and validation is preferred. Scientific Rigor: Ability to design, execute, and iterate experimental protocols, interpret data, and guide cross‑functional teams to advance development. Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and NDA/BLA. Leadership Skills: Proven ability to establish and lead lab operations, manage and mentor multidisciplinary teams, and foster effective cross‑functional collaboration. Results‑Oriented: Strong initiative, accountability, and willingness to take ownership and drive projects to completion. Work independently with CDMOs without close supervision. Collaboration: Proven ability to operate effectively across a matrix organization to drive programs according to timelines; ability to articulate project objectives and priorities. Dynamic Thinking: Sense of urgency and a bias toward action; comfortable challenging the status quo and pushing teams to examine all angles. Communication: Strong written and oral communications skills. Problem‑Solving: Strong analytical skills with a proven track record of overcoming complex scientific challenges. Why Aerogen Pharma As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged. Job Title Associate Director, Product Development #J-18808-Ljbffr