药物产品开发及制造经理

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.

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

Originally posted on Himalayas