Manager, Drug Product Development & Manufacturing

🔥 0 minutes ago

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 $138k - $176k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✅ Product Manager

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Esperion

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Esperion is a leading global biopharmaceutical company focused on developing innovative treatments for cardiovascular disease. Through commercial execution and international partnerships, it aims to provide broad access to its approved therapies. With a commitment to advancing its pre-clinical pipeline, Esperion is pioneering research in ACLY biology and developing next-generation inhibitors to address pressing health challenges.

📋 Description

• 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

🎯 Requirements

• 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%

🏖️ Benefits

• 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