Mgr, Drug Product Development & Manufacturing

Esperion; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Esperion, a fully remote company with an HQ in Ann Arbor, MI, seeks a Manager for Drug Product Development and Manufacturing to support development, tech transfer, and manufacturing of device combination drug products. The role involves working with CMOs, cross-functional teams, and travel up to 25%.

The candidate will oversee technical activities, maintain documentation, and ensure regulatory readiness while driving process improvements and CPV initiatives.

Qualifications

• Bachelors' degree in Pharmaceutical Sciences, Engineering, Chemistry or related field.
• Experience with development and commercialization of device combination drug products.
• Familiarity with device quality system requirements (21 CFR Part 820/4, ISO 13485) and risk management (ISO 14971).
• Experience with GMP device manufacturing in pharmaceutical industry (R&D, process development, manufacturing or contract manufacturing).
• Experience with human factors, dose accuracy and delivery performance, container closures, extractables/leachables.
• Experience with technology transfer of manufacturing processes and process improvements for combination products.
• Experience with contract manufacturers and quality systems in regulated environments (change control, CAPA, deviations).
• Experience working in multi-cultural/multi-lingual environments and cross-functional teams.

Responsibilities

• Support commercial manufacturing of device combination drug products at CMOs, including batch record reviews and on-site technical oversight.
• Collaborate with Tech Ops, Supply Chain, Quality Control/Management, and Regulatory Affairs for timely execution.
• Provide engineering knowledge for injection moulding, valve actuators, metering, tolerances, and spray patterns.
• Maintain DHF, process validation and manufacturing documentation; support regulatory filings.
• Analyze data for CPV and contribute to remediation plans for gaps.
• Coordinate with device suppliers on components, specs, and issue resolution.
• Assist with device/combination-product documentation and inspection readiness.
• Ensure changes consider device requirements and design controls.

Skills

Statistical analysis

Quality systems

Regulatory affairs

Cross-functional teamwork

Vendor management

Education

Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry or related field

Tools

Trackwise

Veeva

Job description

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.
• Domestic and international travel required (up to 25 %).