Process Engineer – Lipid Formulations & GMP Scale-Up

Aerogen Pharma; Foster City (CA); On-site; USD 90,000 - 106,000; Full time

Job summary

Aerogen Pharma in California is seeking a chemical engineering professional to support development of lipid-peptide and lipid-protein formulations in GMP settings. The role spans R&D and Process Development with opportunities to gain CDMO oversight experience and contribute to early and late-stage clinical programs.

You will work hands-on in the lab on process design for stir tank reactors, TFF, lyophilization, and fill-finish operations, while collaborating with analytical and regulatory teams

Qualifications

• 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 or liposomes).
• Calorimetry and lyophilization experience desirable.
• Experience in technical writing required.
• Authoring CMC dossiers for FDA, EMA, and other regulatory agencies desirable.
• Knowledge and experience in drug-device development, specifically inhalation drug delivery, desirable.
• Excellent written and oral communication skills a must.

Responsibilities

• Chemical engineering: Development and optimization of formulation unit-operation methods and support design of experiment studies.
• Materials Science & Fluid Mechanics: Develop 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).

Skills

Process development

Calorimetry

Lyophilization

Analytical development

Data analysis

Technical writing

Drug-device development

Education

Chemical engineering or related field

Job description

Aerogen Pharma in California is seeking a chemical engineering professional to support development of lipid-peptide and lipid-protein formulations in GMP settings. The role spans R&D and Process Development with opportunities to gain CDMO oversight experience and contribute to early and late-stage clinical programs.

You will work hands-on in the lab on process design for stir tank reactors, TFF, lyophilization, and fill-finish operations, while collaborating with analytical and regulatory teams