About Avalyn:
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
Position Overview:
The Senior Scientist, Formulation Development will play a key role in advancing Avalyn's pipeline of inhaled therapies for pulmonary fibrosis. This position will focus on the development and optimization of solution and dry powder formulations, aerosol performance, and drug-device compatibility to support clinical development, process scale-up, and future commercial manufacturing.
This is a hands-on laboratory position focused on formulation development for inhaled therapeutics. The successful candidate will possess deep expertise in formulation development, aerosol science and pulmonary drug delivery and will apply scientific knowledge to develop robust product candidates that support clinical and commercial development.
The Senior Scientist will collaborate closely with Pre-Clinical Development, Analytical Development, Manufacturing, Regulatory Affairs, Quality, and other partners to advance inhaled drug products from early development through late-stage clinical development.
This position is based in San Diego, California and reports directly to the SVP of Product Development.
Key Responsibilities:
Formulation Development
- Design, execute, and document laboratory studies supporting development of inhaled drug products.
- Develop and optimize solution and dry powder formulations for pulmonary drug delivery.
- Design formulation screening studies to improve product performance, manufacturability, and stability.
- Conduct preformulation studies, including pH-solubility, temperature-solubility, excipient compatibility, pH-kinetic, and related characterization studies to inform formulation design and development.
- Evaluate excipients, formulation composition, and processing parameters to optimize aerosol performance.
- Apply Design of Experiments (DoE) methodologies to support formulation optimization.
- Support formulation selection for clinical development.
Aerosol Science & Characterization
- Perform and interpret aerosol characterization studies using standard inhalation testing methodologies.
- Evaluate aerodynamic particle size distribution (APSD), emitted dose, delivered dose uniformity, and fine particle fraction.
- Conduct aerosol performance testing of dry powder formulations and characterize dry powder formulation attributes to support formulation optimization and product development.
- Analyze aerosol performance data and recommend formulation improvements.
- Assess formulation-device compatibility and performance.
- Troubleshoot formulation and aerosol performance issues using scientific investigation and laboratory experimentation.
Laboratory Operations
- Maintain detailed laboratory notebooks and technical documentation in accordance with company procedures.
- Analyze experimental data and prepare technical reports, presentations, and development summaries.
- Ensure laboratory activities are conducted in compliance with applicable quality and safety requirements.
- Maintain laboratory equipment and coordinate analytical testing as required.
- Assist in hiring, onboarding, and managing a laboratory technician to execute formulation development, preformulation, aerosol testing, and characterization studies.
Product Development
- Collaborate with cross-functional development teams to advance inhaled drug products through clinical development.
- Support technology transfer activities to manufacturing sites and CDMOs.
- Participate in process development, scale-up activities, engineering batches, and clinical manufacturing campaigns.
- Support CMC documentation for regulatory submissions, including INDs, IMPDs, briefing documents, and other technical reports.
Technical Leadership
- Provide scientific expertise in formulation development and aerosol science across Product Development.
- Stay current with advances in inhalation technologies and pharmaceutical formulation science.
- Present technical findings to project teams and senior management.
Qualifications:
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Materials Science, or a related scientific discipline is required.
- A minimum of 8 plus years of industry experience in pharmaceutical formulation development following completion of a Ph.D. is required.
- Experience developing inhaled pharmaceutical products is highly preferred.
- Deep understanding of aerosol science and pulmonary drug delivery is preferred.
- Hands-on experience with solution and dry powder inhalation formulations is desirable
- Experience working with inhalation devices and drug-device combination products is preferred
- Strong understanding of formulation characterization techniques, aerosol performance testing, and stability studies is required.
- Experience working with CDMOs and supporting technology transfer is required.
- Demonstrated ability to work independently, take ownership of formulation development activities, and exercise sound scientific judgment.
- Demonstrated ability to work effectively on cross-functional teams.
- Knowledgeable about applicable GMP regulations and quality expectations relevant to pharmaceutical development and laboratory operations.
- Experience supporting products through IND-enabling activities, clinical development, and commercialization is preferred.
- Knowledge of regulatory expectations for inhalation products is preferred.
- Experience with spray drying, particle engineering, or advanced formulation technologies.
- Familiarity with Quality by Design (QbD) principles and pharmaceutical development best practices.