Senior Scientist, Inhalation Drug Delivery & Regulatory Lead

Aerogen Pharma; San Mateo (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company in San Mateo, CA, seeks a Senior Scientist, Product Development to lead late-stage development of AeroFact and the associated biologic/device combination, focusing on regulatory CMC and BLA preparation.

You will manage analytical method development, stability studies, and collaboration with CDMOs/CMOs, working across R&D, Manufacturing, Regulatory and QA to deliver robust data and regulatory submissions.

Qualifications

• Late-stage product development experience is required.
• Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required.
• 5-10 years of product development experience.
• Experience managing CDMOs / Contract Laboratories is required.
• Knowledge of Good Manufacturing Practices is required.
• Experience with sterile manufacturing is a plus.
• Experience with lipid formulations, liposomes, or related drug delivery technologies is a plus.
• Knowledge and experience in drug-device development, and inhalation drug delivery including aerosol characterization techniques is a plus.
• Excellent written and oral communication skills.

Responsibilities

• Prepare and review regulatory submissions (INDs, BLAs, NDAs) for filings.
• Lead analytical development projects with CDMOs and external labs.
• Develop and execute regulatory strategies aligned with standards.
• Manage method validation/transfer for lipid, protein and peptide analyses.
• Design and oversee stability studies for NDA/BLA timelines.
• Coordinate with CDMO/CMO partners to meet timelines.
• Collaborate with R&D, Manufacturing, Regulatory, QA to integrate development goals.
• Troubleshoot analytical issues and implement CAPAs.

Skills

Communication

Stability Management

Regulatory Knowledge

Technical Expertise

Problem-Solving

Results oriented

Education

M.S./M.Sc. or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or related field

Tools

HPLC

LCMS

GCMS

Particle Size Analysis

Aerosol Characterization

Job description

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company in San Mateo, CA, seeks a Senior Scientist, Product Development to lead late-stage development of AeroFact and the associated biologic/device combination, focusing on regulatory CMC and BLA preparation.

You will manage analytical method development, stability studies, and collaboration with CDMOs/CMOs, working across R&D, Manufacturing, Regulatory and QA to deliver robust data and regulatory submissions.