<div> <h3>Company Overview</h3> <p><strong>Our Mission:</strong>At <a href="https://himalayas.app/companies/esperion">Esperion</a>, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.</p> <p><a href="https://himalayas.app/companies/esperion">Esperion</a> is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.</p> <p><strong>Position Title: Manager, Drug Product Development and Manufacturing</strong></p> <p>The Manager, Drug Product Development and Manufacturing is a technical role that supports the development, technology transfer and manufacturing of device combination drug products at contract manufacturing organizations (CMOs). A key component of this technical role is supporting the manufacturing of commercial combination products as well as providing technical expertise for additional development and supply-chain expansion efforts. This is a remote, work from home position with approximately 25% travel.</p> <h3>Preferred Location: Remote – US</h3> <h3>Essential Duties and Responsibilities*</h3> <div><ul> <li>Support activities for commercial manufacturing of device combination drug products at CMOs, including technical review of drug product batch records, on-site “person-in-plant” technical oversight, and support of other manufacturing activities at CMOs as required.</li> <li>Collaborate within Tech Ops and internal project teams including Supply Chain, Quality Control, Quality Management, Regulatory Affairs, as required, for timely execution of combination product manufacturing activities.</li> <li>Provide engineering and technical knowledge to support injection moulding, valve actuator assemblies, metering mechanisms, dimensional tolerances and functional performance, spray pattern and aerodynamic particle size distribution (APSD).</li> <li>Maintain technical documentation of device history (DHF), process validation and commercial manufacturing, and support combination device regulatory filings.</li> <li>Collect, analyze, and summarize data for continuous process verification (CPV) and provide input into remediation plans for identified gaps.</li> <li>Support combination product / device-related technical activities, including coordination with device suppliers/partners on components, specifications, and technical issue resolution.</li> <li>Partner with Quality and Regulatory to help ensure device/combination-product documentation expectations are met (e.g., device master record/device history record inputs where applicable) and support inspection readiness.</li> <li>Ensure manufacturing changes and investigations consider combination-product requirements, including interface with design controls and risk management activit