Manager, Drug Product Development & Manufacturing

🕒 Agosto 6

🚗 Michigan – Remoto

🚗 Michigan – Remote

💵 $138.000 - $176.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 5%

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Esperion

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2008

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

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

• Support commercial manufacturing of device combination drug products at contract manufacturing organizations, including technical review of batch records and on-site person-in-plant technical oversight • Collaborate with Tech Ops and internal project teams, including Supply Chain, Quality Control, Quality Management, and Regulatory Affairs • Provide engineering and technical expertise for injection moulding, valve actuator assemblies, metering mechanisms, dimensional tolerances, functional performance, spray pattern, and APSD • Maintain device history, process validation, and commercial manufacturing documentation • Support combination device regulatory filings • Collect, analyze, and summarize continuous process verification data and provide input into remediation plans • Coordinate with device suppliers and partners on components, specifications, and technical issue resolution • Partner with Quality and Regulatory to meet device and combination-product documentation expectations and support inspection readiness • Ensure manufacturing changes and investigations address combination-product requirements, design controls, and risk management • Create and review technical documents, reports, updates, and presentations for cross-functional teams and management • Perform additional duties and responsibilities as assigned

🎯 Requisitos

• Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, or a closely related field from an accredited college or university • Minimum 4 years of experience with development and commercialization of device combination drug products • Drug-device combination product experience, including familiarity with device quality system requirements such as 21 CFR Part 820/4 and ISO 13485 • Knowledge of risk management principles, including ISO 14971 • GMP device manufacturing experience in the pharmaceutical industry in research and development, process development, manufacturing, or contract manufacturing • Experience with human factors and user error engineering, dose accuracy and delivery performance, container closure systems, and extractables/leachables • Background in device combination development, technology transfer, manufacturing-process troubleshooting, and process improvements • Experience supporting combination products and device-component interfaces • Experience working with contract manufacturers • Hands-on experience with regulated-environment quality systems, including change control, risk management, CAPA, and deviations • Working knowledge and experience with SOPs and ICH guidelines • Experience working in a multicultural, multilingual environment and contributing to a multidisciplinary team • Ability to work in a dynamic, multidisciplinary team environment • Experience in statistical analysis, interpretation, and summary of trending data preferred • Self-motivated, organized, reliable, and responsive • Demonstrated alignment with Esperion's Vision, Mission, Values, and Culture • Proficiency with office and applicable business systems, including TrackWise and Veeva • Excellent written and verbal English communication skills • Domestic and international travel required, up to 25%

🏖️ Benefícios

• Performance-based bonus program • Comprehensive benefits package • 401(k) matching plan • Health insurance • Paid time off • Paid holidays • Remote work from home • Approximately 25% travel