What is the role?
The person in this role is responsible for establishing and maintaining a state-of-the-art aerosol development laboratory for inhaled products, in addition to being well experienced in core analytical techniques used for testing / characterization of instilled and aerosolized surfactant products in development at Aerogen Pharma. This role is crucial for advancing our CMC program for the Aerofact and Synthetic Surfactant projects, as well as establishing aerosol characterization capabilities and in house expertise in our expanding portfolio, ensuring products meet rigorous quality and regulatory standards. The person will be both hands on in the lab with deep technical knowledge, and will collaborate effectively with our external GMP testing and manufacturing partners.
What are the key responsibilities?
• Lab design, establishment and operations: Establish state-of-the-art aerosol testing capabilities (delivered dose, aerodynamic particle size, droplet size among others) and work in collaboration with our laboratory that develops aerosolized surfactant products. Ensure efficient and safe lab operations.
• Analytical methods development for Aerosol and Instilled dosage forms: Lead development and validation of chromatographic / physical / aerosol characterization methods for Aerofact and Synthsurf. Design and conduct laboratory experiments to develop understanding of drug product CQAs and characterize drug product.
• CDMO/CMO Collaboration. Manage analytical activities including method development, transfers and stability studies at CDMO. Ensure effective communication and coordination with our GMP partners to meet project timelines and quality expectations.
• Regulatory Submissions: Prepare and review documentation describing development for regulatory submissions (INDs, CTAs, BLAs, NDAs). Ensure adherence to regulatory requirements.
• Cross-Functional Collaboration: Work closely with R&D, Regulatory, Quality Assurance, and Manufacturing teams to integrate aerosol science efforts within overall project goals.
• Troubleshooting & Problem Solving: Address and resolve complex process issues during aerosol delivery of combination products
• Continuous Improvement: Stay updated on advancements in aerosol delivery technology, techniques and industry trends.
What education and experience are required?
• A Ph.D. in Chemistry, Engineering, Aerosol Physics, Biochemistry or related fields.
• 2-5years of analytical / aerosol sciences hands-on experience in industry
• Knowledge is required in equipment and techniques used for inhalation drug delivery (i.e. delivered dose uniformity, aerodynamic particle size etc.)
• Experience in technical writing is required.
• Excellent written and oral communication skills.
• Experience in lipid formulations, liposomes, or related drug delivery technologies is a plus.
• Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus.
What key skills will make you great at the role?
• Technical expertise: Proficiency in formulation design as it relates to aerosol delivery, and the analytical equipment required to test aerosols is a key strength. Experience with drug-device combination products is a requirement.
• Data-driven decisions: Use lab data to make informed decisions about product development
• Leadership, management and communication skills: Motivate, inspire, and lead technical staff. Clearly and effectively communicate with team members, other departments, and upper management.
• Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to formulation issues. Develop clear strategies and plans to achieve the lab's objectives.
• Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment.
• Compliance and safety: Ensure a safe and complaint work environment.
• Training, procedures, quality: Ensure the aerosol lab meets all relevant quality standards and documentation requirements. Train other employees on aerosol delivery techniques and equipment.
• Regulatory guidelines: Familiar with FDA, USP, and Ph. Eur. guidelines for respiratory products
