Senior Manager, CMC Technical Writing

We need to output HTML fragment with sections: About the role? Actually the posting includes "About Avalyn" then "Position Overview:" then "Key Responsibilities:" then "Qualifications:" then "WORKING AT AVALYN" then "Diversity, Equity, and Inclusion at Avalyn" then "Benefits". We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. However we must only include sections when posting has real specific content. We have content for About Avalyn (company description) maybe "About the role"? The posting has "Position Overview". That could map to "About the role". We'll use heading

About the role

with paragraph(s) from Position Overview. Responsibilities: from Key Responsibilities. Requirements: maybe from Qualifications? Actually Qualifications is separate. Requirements could be qualifications? But we have Qualifications section. We'll treat Qualifications as Requirements? The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need separate headings for Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have content for Responsibilities, Qualifications, Benefits. We may not have explicit Requirements separate from Qualifications; but we could combine Qualifications as Requirements? However they'd be duplicate. Better to treat Qualifications as Requirements? But they also have Qualifications heading in posting. We could map Qualifications to Requirements? But we also have Qualifications heading allowed. So we can include both Requirements and Qualifications if content distinct. The posting's Qualifications section includes education, experience, skills. That could serve as Requirements. The Skills heading could be extracted from within Qualifications (like skills). But we might not have separate Skills section; we could omit if no specific skills list beyond what's in Qualifications. The instruction: Prefer a few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one section? But we need to follow headings list; we can omit sections lacking content. So we will include: About the role, Responsibilities, Qualifications, Benefits. Possibly also Requirements if we can extract from Qualifications? But we might just treat Qualifications as Requirements and not duplicate. However they said use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. It's not mandatory to use all; just examples. So we can choose which to include based on content. Thus we will output:

About the role

Position Overview: ... (the paragraph(s) from Position Overview)

Responsibilities

• ... each responsibility as list items

Qualifications

• ... each qualification bullet
• for any list. We need to preserve all substantive information; do not invent or summarize away detail. So we need to capture all bullet points from Key Responsibilities and Qualifications sections. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes "WORKING AT AVALYN" and "Diversity, Equity, and Inclusion at Avalyn". Those are not in the allowed headings list but could be considered "About the role"? Not exactly. They are company culture. Could be omitted? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The culture sections are not boilerplate; they are substantive about working environment. However we don't have a heading for culture; we could include them under "About the role" maybe? But they'd be separate. The allowed headings list does not include culture; but we could still include a heading like "Working at Avalyn"? Not in list but maybe acceptable? The instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). The "e.g." suggests those are examples, not exclusive. So we could add other headings if needed. But better to stick to those. However we have substantive content about working at Avalyn and DEI. Could we incorporate them into "About the role"? Might be okay but risk losing detail. The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we must keep that info. If we put them under About the role, we are not losing detail, just grouping. That's acceptable. Similarly Benefits section we have details. Thus we will have sections: About the role (includes Position Overview, Working at Avalyn, DEI), Responsibilities, Qualifications, Benefits. We must not include Pay or Schedule as no info. Now extract content. Let's copy relevant text. About Avalyn paragraph: "About AvalynAvalyn 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: "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." We can combine About Avalyn and Position Overview under About the role. Working at Avalyn: "WORKING AT AVALYNWe are a vibrant biotech dedicated to making a meaningful impact in the lives of patients with rare lung diseases. At Avalyn, we are committed to fostering a culture that values collaboration, continuous improvement, and professional growth. We maintain an energetic workplace where open communication, supportive feedback, and a dynamic atmosphere encourage creative thinking and freedom of expression. This results in an empowering environment where our team is inspired to contribute to our mission every day." Diversity, Equity, and Inclusion: "Diversity, Equity, and Inclusion at AvalynDiversity, inclusion, and equity are vital elements of our culture, and we work hard to ensure all voices are welcomed, heard, and respected.Our goal is to continue building a diverse and inclusive workforce at all levels. More than 50% of our organization comprises women, including nearly half its leadership and Board of Directors." Benefits: "BenefitsCompetitive salaries, a rewarding bonus program, and long-term incentive opportunities 401(k) with company match Enjoy flexible schedules and remote work options that support a healthy work-life balance Comprehensive medical, dental, and vision coverage, along with short-term and long-term disability, life, and AD&D benefits Includes vacation days, year-end company closure, holidays and floating holidays, volunteering time, sick and medical leave Tuition reimbursement, continuing education, conference opportunities, and leadership training" We need to format benefits as list items. Now Responsibilities: list from "Key Responsibilities:" bullet points. Let's extract each responsibility line. 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. We need to turn each bullet into

  . Ensure we keep the bold headings? The headings like "Development & Technical Report Writing" are subsection headings; we could keep them as plain text within

  or maybe as . But we should preserve substance; we can keep them as part of the list item text. Now Qualifications: list. 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,