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-IPF, 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:
Reporting to the Director, Product Development, the Associate Director, Analytical Development is responsible for leading the analytical strategy supporting Avalyn's late-stage drug substance and inhalation drug product development and commercial readiness activities. This individual will provide technical leadership for analytical method development, validation, transfer, and lifecycle management to support ongoing Phase 3 inhalation clinical studies, Process Performance Qualification (PPQ) batches, regulatory submissions, and future commercial manufacturing activities. The position works closely with internal cross-functional teams, including Quality, Regulatory Affairs, and Clinical, as well as external CDMO partners, to lead and oversee analytical activities in alignment with the highest scientific, quality, and regulatory standards.
Key Responsibilities:
Analytical Development
- Lead development, optimization, qualification, validation, and lifecycle management of analytical methods to support Avalyn's drug substances and inhalation drug products.
- Design and lead late-stage characterization of inhalation critical quality attributes, including delivered dose, aerodynamic particle size distribution, fine particle dose/fraction, nebulization performance, residual volume, aerosol output rate, droplet/particle size, pH, osmolality, viscosity, impurities, and degradation pathways.
- Develop late-stage inhalation product control strategies that link analytical methods, specifications, stability programs, in-use conditions, and device performance to clinically relevant product quality attributes.
- Define and support E/L control strategies aligned with applicable regulatory guidances.
- Support inhalation product comparability and bridging assessments for process, formulation, device, or supplier changes across development and commercialization.
- Define acceptance criteria needed to support regulatory expectations for inhalation medicinal products, including pharmaceutical development rationale, device compatibility, performance characterization, and lifecycle management.
Method Validation
- Develop and approve validation protocols and reports.
- Ensure validation activities comply with ICH Q2, USP, FDA, EMA, and applicable global regulatory expectations.
- Resolve analytical issues arising during validation and commercial manufacturing.
- Partner closely with internal teams to develop analytical readiness strategies for successful PPQ execution.
- Serve as the analytical lead supporting PPQ batches manufactured at Avalyn's CDMO vendors.
- Review analytical sampling plans, acceptance criteria and data packages supporting clinical, PPQ and commercial release.
- Provide technical oversight for method transfers to contract laboratories and manufacturing partners.
CMC Regulatory Support
- Author and review analytical sections of regulatory submissions, including INDs, IMPDs, CTAs, NDA/BLA Module 3 documentation, annual reports, regulatory responses, and related documents
- Support Health Authority inspections and information requests.
CDMO Management
- Provide scientific oversight of cGMP analytical activities performed by external laboratories and CDMO vendors.
- Review protocols, reports, investigations, deviations, OOS/OOT results, and change controls.
- Ensure vendors meet Avalyn quality and technical expectations.
Cross-Functional Collaboration
- Partner with cross-functional teams, including Product Development, Quality Assurance, Regulatory Affairs, Technical Operations, Manufacturing, Program Management, and other internal stakeholders
- Provide analytical expertise supporting process development, stability, specifications, comparability, and lifecycle management.
Continuous Improvement
- Identify opportunities to improve analytical workflows, documentation, and laboratory efficiency.
- Develop scalable analytical systems to support Avalyn's transition toward commercialization.
Qualifications:
- Ph.D. (or equivalent degree) in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline preferred.
- Master's degree with significant industry experience will also be considered.
- 8+ years of analytical development experience supporting drug substances and inhalation solution drug products in the biotech/pharma or related industry is required.
- Experience with inhalation drug development is desirable and will be given high consideration.
- Strong experience supporting cGMP late-stage development and commercial manufacturing supporting inhalation products.
- Demonstrated experience with analytical method development, validation, and transfer supporting compendial and aerosol methodologies.
- Demonstrated success supporting PPQ campaigns and commercial readiness activities.
- Strong knowledge of inhalation devices and aerosol characterization preferred.
- Proven ability to effectively oversee external CDMOs and contract laboratories.
- Expertise in developing and authoring regulatory and CMC documentation.
- Experience supporting FDA, EMA, and/or global regulatory inspections preferred.
- Deep technical expertise in analytical chemistry, with an emphasis on inhalation development and late-stage commercialization is preferred
- Ability to work independently in a small biotech environment while effectively managing multiple CDMOs and external partners.
- Strong cross-functional leadership and ability to influence without direct authority, while balancing technical detail with strategic development timelines.
- Willingness and ability to travel 10% is required
