Mgr, Drug Product Development & Manufacturing

ESPERION THERAPEUTICS INC•Ann Arbor, MI

3d•$138,000 - $176,000•Remote

About The Position

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.

Requirements

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.
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 %).

Nice To Haves

Experience in statistical analysis, interpretation, and summary (control charts) of trending data preferred.

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.