ESPERION THERAPEUTICS INC

Ann Arbor, MI Job Details $138,000 - $176,000 a year 1 day ago Benefits Paid holidays Health insurance Paid time off 401(k) matching Qualifications Preventive action implementation Production deviation management English ICH guidelines Quality risk management Medical device manufacturing facility experience Pharmaceutical company experience Technology transfer (scale-up process) Engineering product development Biomedical regulatory compliance Technical troubleshooting support Productivity software Biomedical manufacturing processes Ergonomic design

ISO 13485 FDA

regulations Pharmaceutical manufacturing facility experience

Full Job Description 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 regulatory filings. Collect, analyze, and summarize data for continuous process verification (CPV) and provide input into remediation plans for identified gaps. Support combination product / device-related technical activities, including coordination with device suppliers/partners on components, specifications, and technical issue resolution. 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. Ensure manufacturing changes and investigations consider combination-product requirements, including interface with design controls and risk management activities as applicable. Create and review technical documents, reports, updates and presentations for cross-functional teams and management. additional duties and responsibilities as assigned Qualifications (Education & Experience) Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry or closely related field from an accredited college or university, with minimum 4 years of experience with development and commercialization of device combination drug products. Drug device combination product experience required, including familiarity with applicable device quality system requirements (e.g., 21 CFR Part 820/4 and

ISO 13485

) and risk management principles (e.g., ISO 14971) as applicable. Experience in a GMP device manufacturing in pharmaceutical industry either in a research and development, process development, manufacturing, or contract manufacturing role; Experience with human factor and user error engineering, dose accuracy and delivery performance, container closure systems, and extractables/leachables. Solid background in device combination development, technology transfer of manufacturing processes, troubleshooting and process improvements, including experience supporting combination products and device-component interfaces Experience working with contract manufacturers Hands on experience with quality systems in a regulated environment, including change control, risk management, CAPA and deviations. Working knowledge and experience with SOPs and ICH guidelines. Experience working in a multi-cultural, multi-lingual environment is necessary with a demonstrated ability to contribute successfully to a multi-disciplinary team environment. Ability to work in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals. Experience in statistical analysis, interpretation, and summary (control charts) of trending data preferred. Self-motivated, organized, and be reliable and responsive as needed to perform responsibilities. Demonstrated alignment with Esperion's Vision, Mission, Values and Culture. Proficient with office and applicable business systems including: Trackwise, Veeva, etc. Excellent written and verbal English communication skills. 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Mgr, Drug Product Development & Manufacturing