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 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.
This hands-on role is suited for an experienced scientific or technical writer who can translate complex CMC, pharmaceutical development, and drug-device combination product information into concise, traceable, and scientifically defensible documents that support program knowledge management, regulatory readiness, and submission deliverables.
The successful candidate will bring a strong scientific foundation, excellent writing discipline, and the ability to work effectively with subject matter experts to convert technical input into well-structured documents. This role requires sound judgment, attention to detail, and the ability to manage multiple documents and timelines in parallel while maintaining high standards for accuracy and completeness.
Key Responsibilities:
Development & Technical Report Writing
- Lead planning, authoring, review coordination, revision, and finalization of CMC technical development reports and source documents for the drug substance, drug product and device components.
- Prepare integrated reports covering formulation, analytical, aerosol characterization, device, manufacturing process, technology transfer, and other CMC development activities.
- Work with subject matter experts to synthesize data, development rationale, conclusions, and decisions into accurate, cohesive, and scientifically defensible narratives.
- Take ownership and drive documents through structured planning, drafting, cross-functional review, quality control, approval, and finalization while maintaining alignment with program timelines.
- Develop clear document outlines, tables of contents, data presentation plans, and review strategies to support efficient drafting and alignment with stakeholders.
- Ensure technical documents capture the appropriate development history, rationale, critical assumptions, key findings, limitations, conclusions, and recommended next steps.
Cross-Functional Documentation Support
- Partner with internal functions and external development partners, including CDMOs, contract laboratories, device partners, and consultants, to obtain and integrate information required for technical documentation.
- Support consistent document organization, templates, terminology, and standards to improve knowledge transfer and regulatory readiness.
- Facilitate document review meetings, reconcile reviewer comments, and help drive resolution of technical questions or inconsistencies that arise during review.
- Maintain effective communication with project teams to ensure technical writing deliverables are prioritized, appropriately resourced, and aligned with program milestones.
Regulatory Writing Support
- Lead and support CMC content development for regulatory submissions and health authority interactions, including INDs, IMPDs, CTAs, briefing packages, regulatory responses, Master Validation Plans, and related submission content, in partnership with Regulatory Affairs and CMC subject matter experts.
- Ensure consistency and traceability between development reports, source documentation, and regulatory submission content.
- Contribute to preparation of source documentation that supports future regulatory modules, responses to health authority questions, and internal decision-making.
- Review CMC and product development content for clarity, consistency, completeness, and alignment with established regulatory strategy and internal standards.
Qualifications:
- 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.
- A minimum of 5-7+ years of experience in pharmaceutical, biotechnology, drug-device combination product, or related life sciences development, with significant experience preparing scientific, technical, or CMC documentation.
- 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.
- Strong organizational and document management skills, with the ability to manage competing priorities, multiple document workflows, stakeholder input, and collaborative review processes; proficient in Microsoft Word, document templates, reference management, and quality control.
- Scientific curiosity, attention to detail, and sound judgment, with the ability to ask effective questions, clarify technical information and assumptions, and balance technical depth, readability, accuracy, and fit-for-purpose documentation.
- Collaborative and proactive working style, with the ability to influence without direct authority, effectively engage subject matter experts, and keep contributors aligned on document objectives, timelines, and deliverables.
- Ability to work independently and collaboratively in a fast-paced biotechnology environment with changing priorities.
