Aerogen Pharma
Associate Director, Product Development
Aerogen Pharma, California, Missouri, United States, 65018
Join to apply for the
Associate Director, Product Development
role at
Aerogen Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company focused on inhaled drug/biologic and device combinations to transform care for acute and critically ill patients. Our goal is to create medically superior, proprietary, and commercially differentiated products by combining proven therapeutic molecules with a high-performance aerosol delivery system. We are moving into a phase 3 clinical trial for a major neonatal care breakthrough and are partnered with The Bill & Melinda Gates Foundation to develop low-cost surfactant for premature babies with RDS. What is the role? The Associate Director of Product Development oversees key aspects of pharmaceutical development for AeroFact (biologic surfactant) or Synthsurf (synthetic surfactant). The role focuses on phase-appropriate product development of surfactant lyophilized formulations, manufacturing process optimization and scale-up, and product characterization to support pre-clinical and clinical studies. The position will establish and operate Aerogen Pharma’s in-house development laboratory, lead hands-on formulation and process development of lipid/peptide formulations, and collaborate with process engineers, analytical scientists, and lab technicians. It requires expertise with lipid-based formulations, lyophilization, protocol development, and cross-functional experimental execution. 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 implement 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: Design and execute controlled experiments to develop stable, effective drug products for commercialization. Conduct QbD studies to identify CQAs; perform registration-enabling stability studies and product characterization per ICH guidelines. Product Understanding & Characterization: Lead detailed product characterization studies prior to scale-up. CDMO/CMO Collaboration: Act as the primary liaison with external manufacturing and analytical partners to meet timelines and quality expectations. Scale-Up & Tech Transfer: Translate laboratory formulations into scalable processes and oversee transfer to CDMO partners. Regulatory Compliance: Prepare and review regulatory documentation (INDs, BLAs, NDAs) and ensure adherence to cGMP and regulatory requirements. Experience authoring late-stage regulatory dossiers, particularly BLAs, is required. Cross-Functional Collaboration: Work with R&D, Manufacturing, Regulatory, and Quality Assurance groups to integrate product development with project goals. Troubleshooting & Problem Solving: Address formulation, process, and analytical issues; 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 (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 required. Knowledge of drug-device development and 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: Hands-on formulation and process development skills, including homogenization and lyophilization; experience with lipid-based products (peptides/proteins) and lyophilization manufacturing development and validation. Scientific Rigor: Ability to design, execute, and iterate experiments and guide cross-functional teams. Regulatory Knowledge: Understanding of IND and NDA/BLA submission processes. Leadership: Ability to establish and lead lab operations and mentor multidisciplinary teams. Results-Oriented: Initiative, accountability, and ability to drive projects to completion; capable of working with CDMOs with limited supervision. Collaboration: Ability to operate in a matrix organization and articulate project objectives and priorities. Dynamic Thinking: Urgency, bias toward action, and willingness to challenge the status quo. Communication: Strong written and verbal communication skills. Problem-Solving: Strong analytical skills with a record of overcoming complex challenges. Why Aerogen Pharma As a member of Aerogen Group, a leader in high-performance aerosol drug delivery, Aerogen Pharma is at a pivotal stage with opportunities to expand US hubs and learn from leaders in drug development, inhaled devices, and neonatology. We foster an inclusive culture that supports professional development and contributions to transforming neonatal care. Seniority level
Mid-Senior level Employment type
Full-time Job function
Science and Product Management Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Associate Director, Product Development
role at
Aerogen Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company focused on inhaled drug/biologic and device combinations to transform care for acute and critically ill patients. Our goal is to create medically superior, proprietary, and commercially differentiated products by combining proven therapeutic molecules with a high-performance aerosol delivery system. We are moving into a phase 3 clinical trial for a major neonatal care breakthrough and are partnered with The Bill & Melinda Gates Foundation to develop low-cost surfactant for premature babies with RDS. What is the role? The Associate Director of Product Development oversees key aspects of pharmaceutical development for AeroFact (biologic surfactant) or Synthsurf (synthetic surfactant). The role focuses on phase-appropriate product development of surfactant lyophilized formulations, manufacturing process optimization and scale-up, and product characterization to support pre-clinical and clinical studies. The position will establish and operate Aerogen Pharma’s in-house development laboratory, lead hands-on formulation and process development of lipid/peptide formulations, and collaborate with process engineers, analytical scientists, and lab technicians. It requires expertise with lipid-based formulations, lyophilization, protocol development, and cross-functional experimental execution. 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 implement 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: Design and execute controlled experiments to develop stable, effective drug products for commercialization. Conduct QbD studies to identify CQAs; perform registration-enabling stability studies and product characterization per ICH guidelines. Product Understanding & Characterization: Lead detailed product characterization studies prior to scale-up. CDMO/CMO Collaboration: Act as the primary liaison with external manufacturing and analytical partners to meet timelines and quality expectations. Scale-Up & Tech Transfer: Translate laboratory formulations into scalable processes and oversee transfer to CDMO partners. Regulatory Compliance: Prepare and review regulatory documentation (INDs, BLAs, NDAs) and ensure adherence to cGMP and regulatory requirements. Experience authoring late-stage regulatory dossiers, particularly BLAs, is required. Cross-Functional Collaboration: Work with R&D, Manufacturing, Regulatory, and Quality Assurance groups to integrate product development with project goals. Troubleshooting & Problem Solving: Address formulation, process, and analytical issues; 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 (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 required. Knowledge of drug-device development and 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: Hands-on formulation and process development skills, including homogenization and lyophilization; experience with lipid-based products (peptides/proteins) and lyophilization manufacturing development and validation. Scientific Rigor: Ability to design, execute, and iterate experiments and guide cross-functional teams. Regulatory Knowledge: Understanding of IND and NDA/BLA submission processes. Leadership: Ability to establish and lead lab operations and mentor multidisciplinary teams. Results-Oriented: Initiative, accountability, and ability to drive projects to completion; capable of working with CDMOs with limited supervision. Collaboration: Ability to operate in a matrix organization and articulate project objectives and priorities. Dynamic Thinking: Urgency, bias toward action, and willingness to challenge the status quo. Communication: Strong written and verbal communication skills. Problem-Solving: Strong analytical skills with a record of overcoming complex challenges. Why Aerogen Pharma As a member of Aerogen Group, a leader in high-performance aerosol drug delivery, Aerogen Pharma is at a pivotal stage with opportunities to expand US hubs and learn from leaders in drug development, inhaled devices, and neonatology. We foster an inclusive culture that supports professional development and contributions to transforming neonatal care. Seniority level
Mid-Senior level Employment type
Full-time Job function
Science and Product Management Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr