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Associate Director, Analytical Development at Avalyn Pharma - ApplyBlast

Associate Director, Analytical Development

Avalyn Pharma

2 months ago

Remote

Full Time

Director

4 applicants

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About this role

The Associate Director, Analytical Development leads the analytical strategy for late-stage drug substance and inhalation drug product development, overseeing method development, validation, transfer, and lifecycle management to support clinical studies, PPQ batches, regulatory submissions, and commercial manufacturing. This role collaborates with cross‑functional teams and external CDMO partners to ensure analytical activities meet scientific, quality, and regulatory standards.

Responsibilities

Lead analytical method development and validation for inhalation products
Oversee CDMO analytical activities and ensure cGMP compliance
Author regulatory submissions and support health authority inspections

Skills

Qualifications

Ph.D. in Analytical ChemistryMaster's degree in Pharmaceutical Sciences

About Avalyn Pharma

avalynpharma.com

Headquarters

Boston, Massachusetts, United States

Company Size

11-50 employees

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Avalyn Pharma Inc is a clinical-stage biopharmaceutical company developing inhaled therapies to treat rare respiratory diseases, including pulmonary fibrosis and other interstitial lung diseases. The company's approach focuses on delivering inhaled formulations of established medicines directly to lung tissue to potentially enhance efficacy and reduce systemic side effects. Its pipeline includes two clinical-stage programs, AP01 (inhaled pirfenidone) and AP02 (inhaled nintedanib), as well as a preclinical program, AP03, a fixed-dose combination of both agents.