Head of Analytical Development

🕒 6 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👻 Score fantasma 25%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Pulmovant

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

A Pulmovant é uma empresa comprometida em transformar a vida de pacientes com doenças pulmonares por meio do desenvolvimento de terapias inovadoras. Seu principal produto, o mosliciguat, tem como objetivo fornecer um tratamento inalável, de uso único diário, para hipertensão pulmonar, caracterizado por seu mecanismo inovador de ativação de sGC. Com um foco singular em atender às necessidades únicas de pacientes que sofrem de condições pulmonares, a Pulmovant está engajada em extensos ensaios clínicos para avançar suas opções de tratamento pioneiras.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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