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 ofpharmaceutical 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.

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 Pharmas mission and regulatory standards.
Product Development: Research design and execute controlled experiments with high attention to detail to development of stable and effective drug product 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. Experience working on lipid based and / or protein based biologics is required. Experience with lyophilization process development and optimization is a plus.
CDMO/CMO Collaboration: Serve as the primary liaison with external manufacturing / analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations.
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 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.
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: Experience with lipid-based products (including proteins) and drug-device combination products is required.
Experience with manufacturing process development and validation is preferred.
Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and BLA.
Leadership Skills: Proven ability to lead and develop high-performing teams with excellent interpersonal and communication skills.
Results oriented. Strong initiative accountability and willingness to take ownership and drive projects tocompletion. Work independently with CDMOs without close supervision.
Proven ability to operate effectively across a matrix organization to drive programs according to timelines; ability to articulate project objectives and priorities
Dynamic thinker with a sense of urgency and a bias toward action
Must be comfortable and confident challenging the status quo and
pushing the teams to look at issues and opportunities from 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 companys 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.