Senior Scientist, Analytical Development

Senior Scientist, Analytical Development

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.

Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

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

The person in this role will be responsible for key aspects of pharmaceutical development of Aero Fact. The role will focus on late-stage product development of Aerofact and the biologic / device combination product, inclusive of 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.

• Leadership & Strategy: 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.
• 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 essential. 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.
• Regulatory Compliance: Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements.
• 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.

• 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.
• 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.
• Excellent written and oral communication skills.

• 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).
• Stability Management: Experience managing stability programs supporting clinical shelf life and primary stability studies for NDA/BLAs.
• Problem-Solving: Strong analytical skills with a proven track record of overcoming complex scientific challenges. Experience in managing OOS results and analytical investigations.
• Regulatory Knowledge: Deep understanding of regulatory requirements and submission processes for IND and BLA.
• Results-oriented: Strong initiative, accountability and willingness to take ownership and drive projects to completion. Work independently with CDMOs / Contract Laboratories…