Manager, Drug Product Development & Manufacturing

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Assist in the commercial manufacturing of combination device drug products at contract manufacturing organizations, which includes conducting technical reviews of batch records and providing on-site technical oversight.

• Collaborate effectively with Tech Ops and internal project teams, encompassing Supply Chain, Quality Control, Quality Management, and Regulatory Affairs.

• Offer engineering and technical knowledge related to injection moulding, valve actuator assemblies, metering mechanisms, dimensional tolerances, functional performance, spray patterns, and APSD.

• Maintain documentation regarding device history, process validation, and commercial manufacturing.

• Support regulatory filings for combination devices.

• Collect, analyze, and summarize data on continuous process verification, contributing to remediation plans.

• Coordinate with device suppliers and partners to resolve technical issues, specifications, and component quality.

• Collaborate with Quality and Regulatory teams to ensure documentation expectations for devices and combination products are met, while also supporting inspection readiness.

• Ensure that manufacturing changes and investigations comply with combination-product requirements, design controls, and risk management principles.

• Draft and review technical documents, reports, updates, and presentations for cross-functional teams and management.

• Perform additional tasks and responsibilities as needed.

⛳️ Requirements

• A Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, or a related field from an accredited institution.

• At least 4 years of experience in the development and commercialization of combination device drug products.

• Familiarity with drug-device combination products, including knowledge of device quality system requirements such as 21 CFR Part 820/4 and ISO 13485.

• Understanding of risk management principles, including ISO 14971.

• Experience in GMP device manufacturing within the pharmaceutical industry, particularly in research and development, process development, manufacturing, or contract manufacturing.

• Knowledge of human factors and user error engineering, dose accuracy, delivery performance, container closure systems, and extractables/leachables.

• Experience in device combination development, technology transfer, manufacturing process troubleshooting, and process improvement.

• Proven experience in supporting combination products and device-component interfaces.

• Prior experience working with contract manufacturers.

• Practical experience with regulated quality systems, including change control, risk management, CAPA, and deviations.

• Familiarity with SOPs and ICH guidelines.

• Experience working in a multicultural and multilingual environment, contributing to a multidisciplinary team.

• Ability to thrive in a dynamic, multidisciplinary team setting.

• Preferred experience in statistical analysis, interpretation, and summarizing trending data.

• Self-motivated, organized, dependable, and responsive.

• Demonstrated alignment with Esperion's Vision, Mission, Values, and Culture.

• Proficient with office and relevant business systems, including TrackWise and Veeva.

• Excellent written and verbal communication skills in English.

• Willingness to travel domestically and internationally, up to 25% of the time.

🏝️ Benefits

• Performance-based bonus program.

• Comprehensive benefits package.

• 401(k) matching plan.

• Health insurance.

• Paid time off.

• Paid holidays.

• Remote work from home options.

• Approximately 25% travel required.