Associate Director, Drug Substance

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 24%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.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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Pulmovant

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11 - 50 employés

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Pulmovant est une entreprise dédiée à transformer la vie des patients atteints de maladies pulmonaires en développant des thérapies innovantes. Leur produit phare, le mosliciguat, vise à offrir un traitement inhalé quotidien pour l'hypertension pulmonaire, se distinguant par son mécanisme novateur d'activation de la sGC. Avec un objectif unique de répondre aux besoins spécifiques des patients souffrant de pathologies pulmonaires, Pulmovant s'engage dans des essais cliniques approfondis pour faire progresser ses options de traitement pionnières.

Description

• Drive late-stage drug substance development, scale-up, and commercial manufacturing • Partner with internal CMC, Regulatory, and Quality teams to design, optimize, and define robust, scalable drug substance processes • Direct optimization and scale-up of manufacturing processes at external partners • Apply Quality by Design (QbD) and Design of Experiments (DoE) methodologies to establish Critical Process Parameters and Critical Quality Attributes • Lead technical transfer of drug substance processes across global CDMOs • Lead scale-up activities and process validation campaigns in alignment with FDA, EMA, and other regulatory bodies • Oversee commercial-scale manufacturing lines, process consistency, yield optimization, and supply robustness • Ensure compliance with global cGMP and regulatory standards • Establish drug substance control strategies, including impurity profiling and Proven Acceptable Ranges per ICH guidelines • Support authoring and review of CMC sections for global regulatory submissions and responses to agency inquiries • Collaborate with internal and external stakeholders and report to the Sr. Director of Drug Substance Development

🎯 Exigences

• Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline • 8+ years of progressive experience in drug substance development and manufacturing within the pharmaceutical industry, focusing on late-stage development and commercialization • Strong background in managing CDMO relationships and outsourcing strategies • Demonstrated experience in process development, scale-up, and technical transfer • Knowledge of global regulatory requirements and cGMP compliance • Excellent project management, organizational, and leadership skills • Ability to work in a fast-paced, cross-functional environment and influence internal and external stakeholders • In-depth knowledge of material sciences and solid-state characterization, including ssNMR, XRPD, and advanced spectroscopic techniques • Strong written and verbal communication skills • Proven, hands-on experience driving drug substance chemistry, manufacturing, and control (CMC) activities directly supporting a successful NDA submission • Prior experience preparing for, hosting, or managing a successful regulatory Pre-Approval Inspection (PAI) • Recognized Subject Matter Expert in late-stage process characterization, including QbD, PAR/NOR establishment, Fate and Purge of impurities studies, and ICH M7/nitrosamine safety assessments • Highly fluent and well-versed in global ICH guidelines for drug substance development and manufacturing • Experience with inhaled/inhalation products is a plus

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