Manager, Drug Product Development & Manufacturing

🔥 vor 22 Stunden

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 $138.000 - $176.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

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Esperion

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2008

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Esperion ist ein führendes globales biopharmazeutisches Unternehmen, das sich auf die Entwicklung innovativer Behandlungen für Herz-Kreislauf-Erkrankungen konzentriert. Durch kommerzielle Umsetzung und internationale Partnerschaften strebt es an, einen breiten Zugang zu seinen zugelassenen Therapien zu ermöglichen. Mit dem Engagement, seine präklinische Pipeline voranzutreiben, ist Esperion Vorreiter in der Forschung zur ACLY-Biologie und entwickelt Next-Generation-Inhibitoren, um dringende gesundheitliche Herausforderungen zu bewältigen.

Beschreibung

• 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

🎯 Anforderungen

• 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%

🏖️ Vorteile

• 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