Senior Scientist, Inhaled Drug-Device Development

Aerogen Pharma Limited; California (MO); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Professional development opportunities

Collaborative work environment

Competitive salary

Job summary

A clinical-stage specialty pharmaceutical company in California is seeking a Senior Scientist for Product Development to manage pharmaceutical development aspects, including regulatory submissions and late-stage product processes. The ideal candidate will have significant experience in authoring regulatory packages, a strong background in analytical chemistry, and a proven track record in product development. Join a mission-driven team focused on transforming neonatal care while driving your career forward in a collaborative environment.

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.

Responsibilities

• Prepare and review documentation for regulatory submissions (INDs, BLAs).
• Manage analytical development projects for biologics, proteins, and peptides.
• Design and manage stability studies determining retest date/shelf life of products.
• Serve as the primary liaison with external manufacturing/analytical partners.

Skills

Communication

Technical Expertise

Problem-Solving

Regulatory Knowledge

Stability Management

Education

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

Tools

HPLC

LCMS

GCMS

Job description

A clinical-stage specialty pharmaceutical company in California is seeking a Senior Scientist for Product Development to manage pharmaceutical development aspects, including regulatory submissions and late-stage product processes. The ideal candidate will have significant experience in authoring regulatory packages, a strong background in analytical chemistry, and a proven track record in product development. Join a mission-driven team focused on transforming neonatal care while driving your career forward in a collaborative environment.