Senior Scientist- Aerosol Development

Aerogen Ltd.; San Mateo (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Aerogen Pharma in the United States is seeking a Senior Scientist- Aerosol Development to establish and maintain a state-of-the-art aerosol development laboratory for inhaled products. You will lead analytical method development and collaborate with CDMO/CMO partners to advance Aerofact and Synthsurf programs.

The role requires hands-on lab work, deep technical knowledge, and strong communication skills to meet rigorous quality and regulatory standards while aligning with R&D, Regulatory, QA,

Qualifications

• PhD in a relevant field required.
• 2-5 years hands-on analytical/aerosol experience in industry.
• Experience with inhalation drug delivery tech and CQAs is expected.
• Strong technical writing and communication skills.
• Familiarity with regulatory dossiers is a plus.

Responsibilities

• Establish and operate a state-of-the-art aerosol testing lab.
• Lead method development and validation for aerosol and instilled dosage forms.
• Coordinate with CDMO/CMO partners for method transfers and stability studies.
• Prepare documentation for regulatory submissions (INDs, CTAs, NDAs).
• Collaborate with R&D, Regulatory, QA, and Manufacturing teams.
• Troubleshoot complex aerosol delivery issues and drive improvements.
• Stay updated on advances in aerosol delivery technology.

Skills

Aerosol science

Analytical testing

Technical writing

Communication

Regulatory awareness

Education

PhD in Chemistry, Engineering, Aerosol Physics, Biochemistry or related

Tools

Chromatography

Aerosol characterization equipment

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 products.

At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.

We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.

Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries

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

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.

Equal Employment Opportunity

Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.

Job Title
Senior Scientist- Aerosol Development

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