Senior Scientist, Product Development

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

About 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. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.

We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.

Join us as we embark on this breakthrough and become inspired to deliver.

What is the role?

The person in this role will be responsible for key aspects of pharmaceutical development of AeroFact. A key role will be the regulatory authoring and creating a robust BLA submission. The role will focus on late stage product development of Aerofact and the biologic / device combination product, inclusive of the data and studies associated with the development or optimization of analytical methods, product characterization of a lipid-peptide formulation, aerosol characterization of the combination product, and management of drug substance/drug product stability studies supporting clinical and BLA registration.

What are the key responsibilities?

• Regulatory Authoring and Quality Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements.
• Leadership & Strategy: Manage analytical development projects for biologics, proteins, and peptides, managing projects executed at CDMOs / Contract Laboratories and the data they generate. Develop and execute strategies aligned with Aerogen Pharma’s mission and regulatory standards.
• Analytical Methods: Manage method optimization, validation, and transfer for procedures controlling the quality of lipids, proteins, and peptides. Experience with protein and lipid analytical characterization is preferred. Ensure methods are robust and comply with industry standards.
• Stability Management: 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.
• Product Characterization: Design and manage the execution of late stage product characterization studies supporting BLA filing at Contract Laboratories.
• CDMO/CMO Collaboration: Serve as the primary liaison with external manufacturing / analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations.
• Cross-Functional Collaboration: Work closely with R&D, Manufacturing, Regulatory, and Quality Assurance teams to integrate product development within overall project goals.
• Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development. Implement corrective and preventive actions as needed.

What education and experience are required?

• Late-stage product development experience is required.
• Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required.
• M.Sc. or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or related field.
• 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, including homogenization and lyophilization 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.

What key skills will make you great at the role?

• Communication: Strong written and oral communications skills.
• Stability Management: Experience managing stability programs supporting clinical shelf life and primary stability studies for NDA/BLAs.
• Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and BLA.
• Technical Expertise: Proficiency in lipid and protein quantitation and characterization techniques (e.g. HPLC, LCMS, GCMS). Experience with physical characterization techniques (e.g. Viscosity, Particle Size) and/or aerosol characterization techniques (DDU, aPSD).
• Problem-Solving: Strong analytical skills with a proven track record of overcoming complex scientific challenges. Experience in managing OOS results and analytical investigations.
• Results oriented: Strong initiative, accountability and willingness to take ownership and drive projects to completion. Work independently with CDMOs / Contract Laboratories without close supervision.

Why Aerogen Pharma

As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.

We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.

Job Title

Senior Scientist, Product Development

Tel: [phone]

Development Group

Suite 360, San Mateo, California 94402