Aerogen Pharma · 2 weeks ago
Senior Scientist, Analytical Development
San Mateo County, CA
Full-time
Onsite
Mid, Senior Level
3+ years expAerogen Pharma is a US based clinical-stage specialty pharmaceutical company focused on developing inhaled drug/biologic and device combination products. The Senior Scientist in Analytical Development will manage key aspects of pharmaceutical development, including analytical methods, stability studies, and regulatory compliance for late-stage product development.
Pharmaceuticals
Hiring Manager
Audrey Soto
Responsibilities
Manage analytical development projects for biologics, proteins, and peptides, managing projects executed at CDMOs / Contract Laboratories. Develop and execute strategies aligned with Aerogen Pharma’s mission and regulatory standards
Manage method optimization, validation, and transfer for procedures controlling the quality of lipids, proteins, and peptides. Experience with protein and lipid analytical characterization is essential. Ensure methods are robust and comply with industry standards
Design and manage stability studies determining retest date / shelf life of products for late stage clinical development, and primary stability studies defining commercial shelf life for BLA
Design and manage the execution of late stage product characterization studies supporting BLA filing at Contract Laboratories
Serve as the primary liaison with external manufacturing / analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations
Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements
Work closely with R&D, Manufacturing, Regulatory, and Quality Assurance teams to integrate product development within overall project goals
Address and resolve complex analytical issues during development. Implement corrective and preventive actions as needed
Qualification
Required
Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or related field
3-10 years of analytical development experience
Experience managing CDMOs / Contract Laboratories is required
Late stage product development experience is required
Knowledge of Good Manufacturing Practices is required
Excellent written and oral communication skills
Preferred
Experience with sterile manufacturing is a plus
Experience with lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus
Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is a plus
Knowledge and experience in drug-device development, and inhalation drug delivery including aerosol characterization techniques is a plus
Company
Aerogen Pharma
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase