Executive Director – Drug Substance Development & Manufacturing

🕒 Março 26

🚗 Michigan – Remoto

🚗 Michigan – Remote

💵 $320.500 - $365.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Esperion

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2008

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Esperion é uma empresa biofarmacêutica global líder focada no desenvolvimento de tratamentos inovadores para doenças cardiovasculares. Através da execução comercial e parcerias internacionais, visa proporcionar amplo acesso às suas terapias aprovadas. Com um compromisso em avançar seu pipeline pré-clínico, Esperion está liderando pesquisas em biologia ACLY e desenvolvendo inibidores de próxima geração para enfrentar desafios de saúde urgentes.

Descrição

• Overall responsibility for drug substance (API) from preclinical and clinical development through process validation, site qualification, HA approval, commercial manufacturing oversight • Driving process improvements, manufacturing robustness and cost savings • Prepare and align team thinking so that regulatory starting materials (RSM’s), intermediates and API are seamlessly integrated • Site identification, selection (with QA/QC and SC) and management of Contract Manufacturing Organizations (CDMOs/CMOs) • Deliver robust, scalable and cost-effective manufacturing routes and processes for pipeline and commercial products • Execute plans for the validation, site qualification and registration of API processes at all CMO’s as required by cGMP, ICH FDA/EMA • Lead capacity expansions and technology transfers of APIs from one supplier to new suppliers on a global basis • Plan resources and develop mid to long term strategies for technical support to CMOs • Lead author, review, and approve technical reports/regulatory documents for global submissions • Responsible for preparation and management of Drug Substance Development and Manufacturing department budget

🎯 Requisitos

• Bachelor’s of Science Degree, with PhD preferred, in a relevant scientific discipline • Minimum of 15 years of experience in the pharmaceutical industry specifically in clinical and/or pharmaceutical API development and/or manufacturing • Minimum of 8 years of direct line management experience • Experience in pharmaceutical development and manufacturing with a deep understanding of the drug development process • Technical and scientific knowledge to direct manufacturing oversight for clinical and commercial supply activities • Expert knowledge in US and EU ICH/GCP, SOPs and local regulatory requirements • Effective oral, written communication and presentation skills • Team oriented style, with an ability to build collaboration and engagement among both internal and external stakeholders • Strong leadership skills including the ability to develop and communicate a clear strategic vision, motivate team members, and proven success in creating high performing teams

🏖️ Benefícios

• Competitive salary including a performance-based bonus program and stock-based compensation • Comprehensive benefits package including a 401(k) matching plan and health insurance • Paid time off and holidays