Process Engineer

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 person in this role will conduct experimentation, both within R&D & Process Development, to support the development of commercially viable lipid‑peptide and novel lipid‑protein formulations. Additionally, the candidate will gain experience supporting external oversight activities of our manufacturing partners, generating valuable CMC experience in GMP environments. The candidate will be hands on in the lab with strong technical knowledge in process development for various stages of GMP scale up activities, including process design of stir‑tank reactor, TFF, lyophilization, and fill‑finish unit operations.

Opportunities will be available to gain experience in analytical development and CDMO oversight as each program’s needs dictate. Working within the Aerogen Pharma California team will expose the successful candidate to experience in both early and late‑stage clinical program activities and duties other than those listed may arise within the role’s purview.

• Chemical engineering:
  Development and optimization of formulation unit‑operation methods and support design of experiment studies.
• Materials Science & Fluid Mechanics:
  Collaborate with other formulation scientists and engineers to develop appropriate lyophilization cycles for small scale and commercial scale up activities for novel formulations.
• Analytical science:
  Support development efforts by participating in analytical experiments and using specialized equipment, with guidance from analytical staff.
• Cross‑Functional
  
  Collaboration:
  
  Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals. Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs).

• A degree in chemical engineering, biochemical engineering, pharmaceutical science, mechanical engineering, aerospace engineering, or related field.
• 2-5 years of manufacturing process…