Associate Director, Drug Substance

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 15%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 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

🎯 Requirements

• 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