{"id":399129,"url":"https://alion.io/job/avalynpharma-senior-scientist-formulation-development","title":"Senior Scientist, Formulation Development","company":{"id":9864,"name":"Avalynpharma","domain":"avalynpharma.com","url":"https://alion.io/company/avalynpharma","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":162000,"currency":"USD","period":"year","gross":null,"usd_annual":162000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design of Experiments","optional":false},{"name":"GMP","optional":true}],"status":"closed","first_seen_at":"2026-08-21T00:33:25Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-10-27T17:28:03Z","board_verified":false,"closed_at":"2026-10-27T17:28:03Z","days_open":67,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":67},"description":"About Avalyn:\nAvalyn 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.\nPosition Overview: \nThe Senior Scientist, Formulation Development will play a key role in advancing Avalyn's pipeline of inhaled therapies for pulmonary fibrosis. This position will focus on the development and optimization of solution and dry powder formulations, aerosol performance, and drug-device compatibility to support clinical development, process scale-up, and future commercial manufacturing.\nThis is a hands-on laboratory position focused on formulation development for inhaled therapeutics. The successful candidate will possess deep expertise in formulation development, aerosol science and pulmonary drug delivery and will apply scientific knowledge to develop robust product candidates that support clinical and commercial development.\nThe Senior Scientist will collaborate closely with Pre-Clinical Development, Analytical Development, Manufacturing, Regulatory Affairs, Quality, and other partners to advance inhaled drug products from early development through late-stage clinical development.\nThis position is based in San Diego, California and reports directly to the SVP of Product Development.\nKey Responsibilities:\n Formulation Development\nDesign, execute, and document laboratory studies supporting development of inhaled drug products.\nDevelop and optimize solution and dry powder formulations for pulmonary drug delivery.\nDesign formulation screening studies to improve product performance, manufacturability, and stability.\nConduct preformulation studies, including pH-solubility, temperature-solubility, excipient compatibility, pH-kinetic, and related characterization studies to inform formulation design and development.\nEvaluate excipients, formulation composition, and processing parameters to optimize aerosol performance.\nApply Design of Experiments (DoE) methodologies to support formulation optimization.\nSupport formulation selection for clinical development.\n Aerosol Science & Characterization\nPerform and interpret aerosol characterization studies using standard inhalation testing methodologies.\nEvaluate aerodynamic particle size distribution (APSD), emitted dose, delivered dose uniformity, and fine particle fraction.\nConduct aerosol performance testing of dry powder formulations and characterize dry powder formulation attributes to support formulation optimization and product development.\nAnalyze aerosol performance data and recommend formulation improvements.\nAssess formulation-device compatibility and performance.\nTroubleshoot formulation and aerosol performance issues using scientific investigation and laboratory experimentation.\nLaboratory Operations\nMaintain detailed laboratory notebooks and technical documentation in accordance with company procedures.\nAnalyze experimental data and prepare technical reports, presentations, and development summaries.\nEnsure laboratory activities are conducted in compliance with applicable quality and safety requirements.\nMaintain laboratory equipment and coordinate analytical testing as required.\nAssist in hiring, onboarding, and managing a laboratory technician to execute formulation development, preformulation, aerosol testing, and characterization studies.\nProduct Development\nCollaborate with cross-functional development teams to advance inhaled drug products through clinical development.\nSupport technology transfer activities to manufacturing sites and CDMOs.\nParticipate in process development, scale-up activities, engineering batches, and clinical manufacturing campaigns.\nSupport CMC documentation for regulatory submissions, including INDs, IMPDs, briefing documents, and other technical reports.\nTechnical Leadership\nProvide scientific expertise in formulation development and aerosol science across Product Development.\nStay current with advances in inhalation technologies and pharmaceutical formulation science.\nPresent technical findings to project teams and senior management.\nQualifications:\nPh.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Materials Science, or a related scientific discipline is required.\nA minimum of 8 plus years of industry experience in pharmaceutical formulation development following completion of a Ph.D. is required.\nExperience developing inhaled pharmaceutical products is highly preferred.\nDeep understanding of aerosol science and pulmonary drug delivery is preferred.\nHands-on experience with solution and dry powder inhalation formulations is desirable\nExperience working with inhalation devices and drug-device combination products is preferred\nStrong understanding of formulation characterization techniques, aerosol performance testing, and stability studies is required.\nExperience working with CDMOs and supporting technology transfer is required.\nDemonstrated ability to work independently, take ownership of formulation development activities, and exercise sound scientific judgment.\nDemonstrated ability to work effectively on cross-functional teams.\nKnowledgeable about applicable GMP regulations and quality expectations relevant to pharmaceutical development and laboratory operations.\nExperience supporting products through IND-enabling activities, clinical development, and commercialization is preferred.\nKnowledge of regulatory expectations for inhalation products is preferred.\nExperience with spray drying, particle engineering, or advanced formulation technologies.\nFamiliarity with Quality by Design (QbD) principles and pharmaceutical development best practices.\nProposed pay range\n$150,000—$162,000 USD","description_format":"text","description_chars":6993,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","Prescription Drugs","Oncology 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