Associate Director, Drug Product, Pulmovant

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🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 23%

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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

• Serve as a drug product technical leader for formulation and process development, scale-up, process characterization, technology transfer, and validation through external CDMOs • Apply Quality by Design (QbD) principles to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) and develop a robust control strategy • Compile, analyze, and trend drug product performance data and stability results using statistical tools such as JMP; summarize findings and recommend process or specification actions • Manage CDMO technical deliverables and review master batch records, protocols, and technical reports for accuracy, completeness, and GMP compliance • Support commercial launch activities, including process performance qualification (PPQ) planning and execution and pre-approval inspection (PAI) readiness • Provide scientific oversight of drug product and inhaler compatibility, container closure systems, and aerosol performance • Represent CMC on cross-functional project teams, maintaining timelines and action items to ensure uninterrupted supply of clinical trial material • Lead drug product contributions to CMC submissions, including authoring Module 3 content and responding to agency inquiries • Provide technical guidance to cross-functional team members and external partners

🎯 Requirements

• BS, MS, or PhD in pharmaceutical sciences, pharmaceutics, chemical engineering, chemistry, or a related field • 10+ years of drug product development experience, including substantial work with inhalation products and late-stage development • Demonstrated ownership of external CDMO activities and technical deliverables for a drug product advancing toward registration • Hands-on knowledge of inhalation formulation and process scale-up, drug and device compatibility, and aerodynamic performance testing • Working knowledge of cGMP, ICH guidelines, process validation, stability requirements, and regulatory expectations for combination products • Experience with Module 3 CMC documentation and NDA or MAA preparation for an inhaled product preferred • Ability to analyze data, assess technical risks, and drive decisions across internal functions and external partners • Comfort taking direct accountability in a lean development organization

🏖️ Benefits

• Equal employment opportunities and protection from discrimination and harassment • Collaboration and innovation through the Roivant family of companies