Associate Director, Analytical Development

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $18 000 - $205 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 3%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Avalyn Pharma

Site WebLinkedInTous les Emplois

11 - 50 employés

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Avalyn Pharma est une entreprise biopharmaceutique dédiée au développement de médicaments innovants visant à traiter les maladies pulmonaires rares. L'entreprise mène actuellement l'étude MIST, un essai clinique de Phase 2b évaluant la sécurité et l'efficacité d'une version inhalée de la pirfénidone, connue sous le nom d'AP01, pour les patients diagnostiqués avec une fibrose pulmonaire progressive (FPP). Grâce à ses recherches, Avalyn Pharma cherche à améliorer la fonction pulmonaire et la qualité de vie globale des personnes souffrant de cette condition grave.

Description

• Lead analytical strategy for late-stage drug substance and inhalation drug product development and commercial readiness • Lead development, optimization, qualification, validation, transfer, and lifecycle management of analytical methods • Design and lead characterization of inhalation critical quality attributes • Develop inhalation product control strategies linking methods, specifications, stability, in-use conditions, and device performance • Support comparability and bridging assessments for process, formulation, device, and supplier changes • Develop and approve validation protocols and reports • Resolve analytical issues during validation and commercial manufacturing • Support analytical readiness and serve as analytical lead for PPQ batches at CDMO vendors • Review sampling plans, acceptance criteria, and data packages for clinical, PPQ, and commercial release • Provide technical oversight for method transfers to contract laboratories and manufacturing partners • Author and review analytical sections of INDs, IMPDs, CTAs, NDA/BLA Module 3 documents, annual reports, and regulatory responses • Support Health Authority inspections and information requests • Oversee cGMP analytical activities performed by external laboratories and CDMOs • Review protocols, reports, investigations, deviations, OOS/OOT results, and change controls • Partner with Product Development, Quality Assurance, Regulatory Affairs, Technical Operations, Manufacturing, Program Management, and other stakeholders • Provide analytical expertise for process development, stability, specifications, comparability, and lifecycle management • Improve analytical workflows, documentation, laboratory efficiency, and scalable analytical systems

🎯 Exigences

• Ph.D. or equivalent degree preferred; Master's degree with significant industry experience also considered • 8+ years of analytical development experience supporting drug substances and inhalation solution drug products is required • Experience with inhalation drug development desirable and highly considered • Strong experience supporting cGMP late-stage development and commercial manufacturing for inhalation products • Experience with analytical method development, validation, and transfer for compendial and aerosol methodologies • Experience supporting PPQ campaigns and commercial readiness activities • Strong knowledge of inhalation devices and aerosol characterization preferred • Ability to oversee external CDMOs and contract laboratories • Expertise in developing and authoring regulatory and CMC documentation • Experience supporting FDA, EMA, and/or global regulatory inspections preferred • Technical expertise in analytical chemistry, inhalation development, and late-stage commercialization preferred • Ability to work independently in a small biotech environment while managing multiple CDMOs and external partners • Cross-functional leadership and ability to influence without direct authority • Willingness and ability to travel 10% required