Process Engineer

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 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

What is the role?

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.

What are the key responsibilities?

• 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).

What education and experience are required?

• A degree in chemical engineering, biochemical engineering, pharmaceutical science, mechanical engineering, aerospace engineering, or related field.
• 2-5 years of manufacturing process development experience.
• Experience in colloidal material R&D (lipid formulations, liposomes, or related drug delivery technologies). Calorimetry and lyophilization experience are desirable.
• Experience in technical writing is required.
• Authoring CMC dossiers for FDA, EMA, and other regulatory agencies are desirable.
• Knowledge and experience in drug‑device development, specifically inhalation drug delivery, is desirable.
• Excellent written and oral communication skills a must.

What key skills will make you great at the role?

• Technical expertise: Proficiency in process development, calorimetry, formulation design, and lyophilization. Experience with drug‑device combination products is desirable. Strong understanding of laboratory procedures, equipment, software, and data analysis.
• Data‑driven decisions: Use data and literature research to make informed decisions about operations, budget, and performance.
• Problem‑solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab’s objectives.
• Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast‑paced environment.
• Compliance and safety: Ensure a safe and complaint work environment.
• Training, procedures, quality: Ensure up to date training on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements.

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.

Equal Employment Opportunity

Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.

Salary Range and Benefits

Salary Range for this position is estimated at $90,000-$106,000 and will depend on the candidate's skills, qualification and experience.

The role is eligible for a performance‑based incentive bonus and comprehensive benefit package including:

• Medical, Dental, and Vision Coverage
• 401k Retirement
• Enhanced Global Life Insurance
• Paid Time Off (15-20 days tenure related)
• Global EAP Program
• Short‑Term Disability
• FMLA Benefits

The company reserves the right to adjust this pay range at any time.

Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications.