Head of Analytical Development

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👻 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

• Lead the analytical development function across drug substance and drug product, including leadership, mentoring, and development of analytical team leads and scientists • Own the integrated analytical control strategy from drug substance through drug product, including specifications and their justification, in alignment with relevant regulatory guidelines • Provide hands-on technical leadership in solid-state and particle characterization of drug substance and establish API specifications grounded in drug product performance • Oversee drug product analytical activities for inhalation products, including aerodynamic particle size distribution by cascade impaction, delivered dose uniformity, content uniformity, impurities, moisture, and device-related performance testing • Oversee method development, validation, transfer, and lifecycle management • Direct drug substance and drug product stability programs across CDMOs and contract laboratories, ensuring consistent standards and data integrity across sites • Serve as analytical lead for regulatory submissions and inspections, including authoring and reviewing CTD Module 3 analytical sections, contributing to health authority meeting packages and responses, and leading analytical readiness for pre-approval inspections and CDMO audits • Partner with Quality on analytical deviations, out-of-specification and out-of-trend investigations, change controls, and transition of release and stability testing to commercial quality control • Contribute technical due diligence to selection and qualification of CDMOs and contract laboratories, and manage external partners, resources, and budgets • Participate in cross-functional teams to align analytical strategies with program goals and timelines, including process validation (PPQ) and launch readiness • Travel to CDMO and partner sites as required

🎯 Requirements

• PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Physical or Materials Chemistry, or a related discipline, with 15+ years of pharmaceutical industry experience in analytical development • Candidates with an MS and significant additional relevant experience will be considered • 8+ years of leadership experience in analytical chemistry, including leading an analytical function spanning drug substance and inhaled drug product, managing managers, and building and developing high-performing teams • Demonstrated experience leading analytical activities for a small molecule program through NDA/MAA submission and pre-approval inspection • Experience authoring CTD Module 3 analytical sections and engaging with health authorities • Deep expertise in solid-state and particle characterization, including XRPD, DSC/TGA, DVS, Raman/IR, SEM, laser diffraction, and amorphous content quantification • Experience with micronized APIs • Experience with orally inhaled drug products, preferably carrier-based dry powder inhalers • Experience with cascade impaction, delivered dose uniformity, and the relationship between API attributes and drug product performance • Hands-on experience supporting drug substance process and site changes, including synthetic route changes, comparability assessments, and impurity qualification • Experience overseeing analytical work at multiple CDMOs and contract laboratories • Profound knowledge of current ICH, FDA, and EMA guidelines, including guidance for orally inhaled drug products, and cGMP requirements • Strong strategic, communication, and collaboration skills • Ability to align analytical strategy with development and regulatory goals, manage timelines and budgets, and resolve technical and interpersonal conflict constructively across internal and external teams

🏖️ Benefits

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