Mgr, Drug Product Development & Manufacturing

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 in Ann Arbor, MI.

About the Role

This 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 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.

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, and Regulatory Affairs, as required, for timely execution of combination product manufacturing activities.
• Provide engineering and technical knowledge to support injection molding, valve actuator assemblies, metering mechanisms, dimensional tolerances, 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.
• 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, with a minimum of 4 years of experience in the 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 GMP device manufacturing in the pharmaceutical industry, either 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.
• 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 with a demonstrated ability to contribute successfully to a multi-disciplinary team.
• 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, 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.
• Domestic and international travel required (up to 25%).

Benefits

• Competitive salary including a performance-based bonus program.
• Comprehensive benefits package including a 401(k) matching plan and health insurance.
• Paid time off and holidays.