Process Engineer - Lipid Formulations & GMP Scale-Up

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

Benefits offered by this job

Medical, Dental, Vision

401k Retirement

Life Insurance

Paid Time Off

EAP Program

Short‑Term Disability

FMLA Benefits

Job summary

Aerogen Pharma in California is seeking a lab‑based process development professional to advance lipid‑peptide and novel lipid‑protein formulations. You will support GMP scale‑up, design experiments, and work closely with manufacturing partners to strengthen CMC capabilities.

The role provides exposure to early and late‑stage programs, analytical development, and CDMO oversight while collaborating with cross‑functional teams in a fast‑paced environment.

Qualifications

• Degree in chemical/biochemical/pharmaceutical related field.
• 2-5 years of manufacturing process development experience.
• Experience in colloidal material R&D (lipid formulations, liposomes).
• Experience in technical writing is required.
• Authoring CMC dossiers desirable.
• Knowledge of drug-device development and inhalation drug delivery desirable.
• Excellent written and oral communication skills.

Responsibilities

• Develop and optimize formulation unit‑operation methods and support design of experiment studies.
• Collaborate to develop lyophilization cycles for small and large scale.
• Support analytical development with experiments and data collection.
• Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs).

Skills

Process development

Lyophilization

Calorimetry

Inhalation drug delivery

Technical writing

Data analysis

Collaboration

Problem solving

Education

Bachelors in chemical engineering, biochemical engineering, pharmaceutical science, mechanical engineering, aerospace engineering, or related field

Tools

GMP environments

Job description

Aerogen Pharma in California is seeking a lab‑based process development professional to advance lipid‑peptide and novel lipid‑protein formulations. You will support GMP scale‑up, design experiments, and work closely with manufacturing partners to strengthen CMC capabilities.

The role provides exposure to early and late‑stage programs, analytical development, and CDMO oversight while collaborating with cross‑functional teams in a fast‑paced environment.