Mgr, Drug Product Development & Manufacturing

Company Overview Our Mission: At Esperion , we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. Esperion 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. Position Title: Manager, Drug Product Development and Manufacturing 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. Preferred Location: Remote – US Essential Duties and Responsibilities* 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. 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. 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). Maintain technical documentation of device history (DHF), process validation and commercial manufacturing, and support combination device regula