Remote Manager, Drug Product Development & Manufacturing

Esperion; United States; Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Statistical analysis

Quality systems

Regulatory affairs

Cross-functional teamwork

Vendor management

Ausbildung

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

Tools

Trackwise

Veeva

Jobbeschreibung

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.