Associate Director, Analytical Development

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Avalyn Pharma

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Avalyn Pharma is a biopharma company dedicated to developing innovative medicines aimed at treating rare lung diseases. The company is currently conducting the MIST Study, a Phase 2b clinical trial assessing the safety and efficacy of an inhaled version of pirfenidone, known as AP01, for patients diagnosed with Progressive Pulmonary Fibrosis (PPF). Through their research, Avalyn Pharma seeks to improve lung function and the overall quality of life for individuals suffering from this serious condition.

📋 Description

• Lead analytical strategy for late-stage drug substance and inhalation drug product development and commercial readiness • Lead development, optimization, qualification, validation, transfer, and lifecycle management of analytical methods • Design and lead characterization of inhalation critical quality attributes • Develop inhalation product control strategies linking methods, specifications, stability, in-use conditions, and device performance • Support comparability and bridging assessments for process, formulation, device, and supplier changes • Develop and approve validation protocols and reports • Resolve analytical issues during validation and commercial manufacturing • Support analytical readiness and serve as analytical lead for PPQ batches at CDMO vendors • Review sampling plans, acceptance criteria, and data packages for clinical, PPQ, and commercial release • Provide technical oversight for method transfers to contract laboratories and manufacturing partners • Author and review analytical sections of INDs, IMPDs, CTAs, NDA/BLA Module 3 documents, annual reports, and regulatory responses • Support Health Authority inspections and information requests • Oversee cGMP analytical activities performed by external laboratories and CDMOs • Review protocols, reports, investigations, deviations, OOS/OOT results, and change controls • Partner with Product Development, Quality Assurance, Regulatory Affairs, Technical Operations, Manufacturing, Program Management, and other stakeholders • Provide analytical expertise for process development, stability, specifications, comparability, and lifecycle management • Improve analytical workflows, documentation, laboratory efficiency, and scalable analytical systems

🎯 Requirements

• Ph.D. or equivalent degree preferred; Master's degree with significant industry experience also considered • 8+ years of analytical development experience supporting drug substances and inhalation solution drug products is required • Experience with inhalation drug development desirable and highly considered • Strong experience supporting cGMP late-stage development and commercial manufacturing for inhalation products • Experience with analytical method development, validation, and transfer for compendial and aerosol methodologies • Experience supporting PPQ campaigns and commercial readiness activities • Strong knowledge of inhalation devices and aerosol characterization preferred • Ability to 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 • Technical expertise in analytical chemistry, inhalation development, and late-stage commercialization preferred • Ability to work independently in a small biotech environment while managing multiple CDMOs and external partners • Cross-functional leadership and ability to influence without direct authority • Willingness and ability to travel 10% required