Backed by Norwest.
About the role
The Senior Manager, CMC Technical Writing will author, coordinate, and manage high-quality scientific and technical documentation supporting Avalyn’s CMC and product development programs. Reporting to the Sr. Director, Product Development, this individual will work closely with internal technical functions, Regulatory Affairs, Quality, and external partners to ensure development activities, data, decisions, and conclusions are documented clearly, accurately, and consistently.
What they're looking for
- A minimum of a Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific or technical discipline required, Advanced degree (e.g., MS, PharmD, PhD or equivalent) preferred
- Demonstrated ability to independently author complex CMC, pharmaceutical development, or combination-product technical reports
- Experience authoring and reviewing Design History File (DHF) documentation for drug-device combination products is considered a strong asset
- Strong understanding of pharmaceutical development, including one or more of the following: formulation, analytical, process, manufacturing, device, or combination-product development
- Experience with inhaled products, drug-device combination products, late-stage clinical development, CDMOs, contract laboratories, or external partners is highly desirable
- Excellent written and verbal communication skills, with strong attention to scientific accuracy, data integrity, consistency, traceability, and detail
More about this role
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...
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