Position Title: Manager, Drug Product Development and ManufacturingThe 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 %).
